ASSIGNMENT

Topic: Importance quality control and quality assurance for

thenational and international accreditation
Quality Assurance & Quality Control (PHR428)
Department of Pharmaceutical Sciences
Section - 04

Submitted to:
Dr. Manik Chandra Shill
Associate Professor
Department of Pharmaceutical Sciences
North South University

Submitted by:

Name ID
Tanvir Hossain 1911545049
Israt Jahan Borsha 1821510049
Nakshi Islam 1911029649
Mashiur Rahman Fahad 1821851049
Mustafa al Hakim 1610221049
FAYSAL HOSSAIN 1821456649
Date of Submission: 15/11/2022
Importance quality control and quality assurance for
thenational and international accreditation

Introduction:
Any product's quality is a vital consideration. Quality has evolved into a key differentiator in
the market for practically all items due to the intense competition on the market and
requirements for national and international accreditation. A successful firm must have quality
control in order to achieve national and international accreditation and deliver goods that
meet or surpass client expectations. Additionally, it serves as the cornerstone of a productive,
waste-free company that maximizes output. A sound basis is provided by a quality control
system built on a recognized standard, such ISO 9001, which was released by the
International Organization for Standardization, for obtaining a variety of marketing and
operational advantages.

The two methods are quality control and quality assurance which employed by manufacturers
to maintain or improve the quality of the pharmaceutical product. These two procedures
guarantee that the finished product complies with the specifications and standards established
for the product's quality.One of the most crucial steps in the entire medication manufacturing
process is quality assurance. It will not only enable businesses to safeguard their reputations
but also spare them from harsh fines from regulatory bodies.Pharmaceutical quality control is
used to make sure that the drugs being produced will have the desired effect on the patient.
Additionally, quality assurance ensures that there are no contaminants present and that the
pharmaceuticals will adhere to all applicable laws and standards for quality.Pharmaceutical
quality assurance and control have a number of objectives that they must achieve. A
manufacturer may be subject to expensive fines and even legal proceedings, such as national
and international sanctions, which could endanger the company, if they fall short of these
objectives.The need for quality control and quality assurance of pharmaceutical products is
immense in marketing products in national and international markets. Pharmaceutical
companies are able to market their products by fulfilling the requirements of the national and
international markets which are given by the Marketing Authority.So this is important to
maintain the quality of the pharmaceutical product for the national and international
accreditation.

The Inter-relation of QA, QC and GMP: The maker of pharmaceuticals must make
sure that all manufacturing techniques, to the extent that they are a component of a registered
procedure, are carried out in accordance with the guidelines of a product license that has been
authorized by the licensing authorities. The production process must undergo routine
inspections by the manufacturer while taking technological and scientific advancements into
account. Changes to the registered procedures must be reported to the proper authorities if
they happen. Because of this, it's crucial to implement and run a Quality Assurance (QA)
system that is effective and reliable.All factors that could affect a product's quality are
covered by QA.As a result, specific requirements must be followed in order to obtain the
required drug quality. QA starts with pharmaceutical research since there are connections
between QA, Quality Control (QC), and Good Manufacturing Practice (GMP).
Among other things, QA makes ensuring that the management level's scope of responsibility
is precisely defined and that staff members receive ongoing training to stay current. Training
needs to incorporate theory as well as QA and GMP. There must be established and followed
hygiene programs. It is necessary to thoroughly inspect and approve the facilities and
equipment used. For the practical application of qualification and documentation, QA
stipulates standards.QA conducts routine checks to ensure that every batch can be tracked
back using the documentation, that production and Quality Control procedures are specified,
that production processes are carried out in accordance with GMP and that every
manufacturing procedure and every significant change in process is validated.Self-inspections
are conducted as part of the QA system, and ideas can result in the improvements that are
required. Product distribution and storage procedures should be appropriate, followed, and
controlled in compliance with GMP rules. This ensures that goods are made and tested in
conformity with the registration papers and the company's Quality Standards (QS).When
necessary, QA helps to set up a system that allows generated batches to be pulled from
delivery or sales so that complaints may
be investigated and appropriate steps
can be made to avoid recurrence. The
illustration below shows how closely
QA is connected to GMP and QC and
production.
GMP specifically refers to the portions
of QA that ensure products are
produced and assessed in accordance
with continuous QS. QA encompasses a
wide range of procedures.
Pharmaceutical production and quality
control (QC) are given distinct roles in
GMP Guidelines. The task of general measures is given to QA.Pharmaceutical manufacturing
ensures that a consistent and reliable level of product quality is maintained. QC is the area of
GMP that deals with organization, documentation, release procedures, specimen tests,
specifications, and examinations.
Additionally, QA encompasses all general actions required to maintain acceptable production
standards. QA serves as the connecting thread between all general measures and GMP
(including production and quality control).

Differences between QA and QC:

A part of quality management is quality assurance. A collection of procedures and activities
known as quality assurance (QA) take place while a product is being developed to help
guarantee a high-quality release. Teams from across the software development organization
participate in QA, where they discuss, plan, and execute tests to verify the quality of the final
result.
A division of QA is quality assurance. Teams in QC make sure the finished product satisfies
the organization's quality standards. Software product flaws like user interface errors, poor
design, accessibility problems, or security holes can permanently harm a company's
reputation. company can correct products using a methodical QC process to make The sure
they satisfy both business and customer expectations.

QA begins right at the beginning of a project, adding certain crucial guardrails that keep
products under scope and make them testable. QA even has an impact on how programmers
carry out their duties because its main objective is to create a framework to reduce defects
from the start. While QC responds to the developed product by discovering and either
resolving or prioritizing remaining flaws, QA affects how quality will be implemented and
ensured in a product.
QA happens at every stage of the software development life cycle (SDLC). QA is a continual
endeavor to implement, enforce, and assure digital quality; it is not a stage in the
development process. However, QC can only be performed when a developed product is
available for testing. Both before and after a product's first release, quality control might
occur.Training, documentation, monitoring, and audits are some of the activities and
practices that QA primarily focuses on in order to improve quality. To uncover flaws that
persist after development, QC concentrates on the finished product. QC experts discover
these problems using a range of techniques, such as beta or canary testing and software
analysis.

Differences Between QA and QC

Quality Assurance Quality Control

Proactive Reactive
 Throughout the SDLC After development

About all process About all product

Prevents defects Identifies defects

Organization-wide Team-wide

Strong development methods, including quality-oriented ones like test-driven development,

can reduce the number of faults that make it to the QC stage and even fewer that reach
customers. QA aims to stop some errors from ever happening by coordinating teamwork and
employing techniques like code reviews. Testers detect and rank the remaining flaws using
QC. Although the emphasis is different, the overall objective is the same.
QA is genuinely a company-wide endeavor. There will simply be too many faults getting past
QC if the business side, development side, and testing side can't come to terms on standards
for software quality through a framework like Scrum. QA aids in directing product
development so that when it is received by a smaller QC team, those people will be able to
carry out their tests with the resources and time provided.

Major Regulatory Agencies World Wide and their work:

There are various organizations that must be adhered to globally and are renowned for their
distinct rules in the pharmaceutical industry.
1. World Health Organization (WHO)
2. International Organization for Standardization (ISO)
3. International Conference on Harmonization (ICH).
Regulatory agencies of individual countries:
Each nation has a separate regulatory body in charge of overseeing the pharmaceutical and
healthcare items sold there. The world's health care regulatory organizations are listed below
by country.

Country Regulatory Authorities

EMEA (European Medicine Evaluation

Europe
Agency)
 ❖ CDSCO (Central Drug Standard
Control Organization)
❖ AYUSH (Ministry of Ayurveda,
India
Yoga & Naturopathy, Unani, Siddha
and
Homoeopathy)

❖ USFDA (Food and Drug

Administration)
❖ DHHS (Department of Health &
US Human Services)
❖ NCCAM (National Center for
Complementary Alternative
Medicine)

MHRA (Medicines & Healthcare Products

UK
Regulatory Authority)

Australia TGA (Therapeutic Goods Administration)

China SFDA (State Food Drug Administration)
Brazil National Health Surveillance Agency

❖ World Health Organization (WHO)

WHO is a specialized organization of the United Nations for health.WHO is the leading
global authority on health. It is accountable for exercising leadership in concerns of global
health by defining the agenda for health research, establishing norms and standards, outlining
evidence-based policy alternatives, offering
technical assistance to developing nations, and
observing and analyzing health trends.A global
health organization was one of the topics that
diplomats addressed in 1945 when they came
together to build the United Nations. World
Health Day is celebrated on April 7, which is
also the anniversary of the founding of the
WHO.
Functions of WHO:
WHO is in the role of providing leadership on issues pertaining to global health, establishing
norms and standards, defining evidence-based policy alternatives, setting norms and
standards, offering technical assistance to nations, and monitoring and assessing health
trends. The functions of WHO described below in brief:
✓ Serving as the worldwide health work's directing coordinating authority
✓ To offer assistance to governments in enhancing health care upon request.
✓ Providing the required relief in times of need and adequate technical assistance upon
request from the government
✓ To advance efforts to eradicating endemic, epidemic, and other diseases
✓ Promote the conducting out of research in the area of health
✓ To create, implement, and promote global standards for food, biological, and
pharmaceutical products.
✓ To offer advice and assistance in the area of health.
✓ To encourage higher standards of instruction and training in the health and medically
linked fields.
✓ To create and maintain productive relationships with the UN, specialized
organizations, and government-run health administration professional groups

❖ ICH (International Conference on Harmonization)

The pharmaceutical industry and worldwide drug regulatory agencies are brought together
through the International Council for Harmonization of Technical Requirements for
Pharmaceuticals for Human Use (ICH). In order to develop and approve safe, effective, and
high-quality medicines in the most resource-
effective way possible, ICH seeks to achieve
more global standardization. In conjunction
with EU Member States, the European
Medicines Agency (EMA) supports the
European Commission's participation in ICH
and is a significant player in the creation and
application of ICH guidelines.
Functions of ICH:
Technical standards and ICH guidelines include:
✓ Making suggestions to achieve greater uniformity in the interpretation and application
of technical requirements and guidelines for the registration of pharmaceutical
products and the maintenance of such registrations.
✓ Maintaining a forum for constructive discussion of scientific issues regarding the
harmonization of the technical specifications for pharmaceutical products between
regulatory bodies and the pharmaceutical industry.
✓ To make an international contribution to public health protection in the interest of
patients.
✓ to keep track of and update standardized technical specifications that will increase the
mutual recognition of research and development data
 ✓ to prevent divergent future requirements through the harmonization of a few topics
required by therapeutic advancements and the creation of new technologies for the
manufacture of pharmaceuticals
✓ To make it simpler for new or improved technical research and development methods
to replace or update existing practices
✓ To promote the proper use and integration of common standards through the
coordination of training on standardized guidelines and their use as well as their
dissemination, communication, and information sharing;

❖ FDA (Food and Drug Administration)

FDA also may be described as the world's most significant consumer protection organization.
Its drug approval choices directly influence the testing,
approval, availability, and distribution of prescription
medications around the world. As a regulatory body with
a mostly scientific function, it influences pharmaceutical
research and drug access globally. The FDA is a
scientific organization that works with other highly
qualified and specialized experts such as doctors,
pharmacists, biologists, biochemists, engineers, and
biostatisticians.

Functions of FDA:
FDA regularly monitors medication manufacturers' compliance with its Current Good
Manufacturing Practice (CGMP) requirements to assure the quality of drug products. The
minimal standards for the processes, settings, and controls utilized in the creation, processing,
and packaging of a drug product are laid forth in the CGMP laws for pharmaceuticals. The
rules ensure that a product is safe to use, that it has the components and strength it purports to
have, and that it is labeled accurately.
Examination of the manufacturer's adherence to the CGMPs is part of the approval process
for new and generic drug marketing applications. FDA assessors and inspectors verify
whether the company has the required resources, machinery, and expertise to produce the
medication it proposes to market.
Title 21 of theCodes Federal of Regulation (CFR), which interprets the Federal Food, Drug,
and Cosmetic Act and associated laws like the Public Health Service Act, contains the FDA's
section. The regulations outline the standards that drug producers, applicants, and the FDA
must meet in order for the regulatory process to be understood by all parties.
➢ 21 CFR Part 314-For FDA approval to market a new medicine.
➢ 21 CFR Part 210- Current Good Manufacturing Practice for the Manufacturing,
Processing, Packing, or Holding of Drugs.
 ➢ 21 CFR Part 211-cGMP for Finished Pharmaceuticals products.
➢ 21 CFR Part 212- cGMP for Positron Emission Tomography Drug.

❖ TGA (Therapeutic Goods Administration)

The TGA is in responsible to carry out assessment and monitoring tasks to make sure that
therapeutic goods offered in Australia adhere to
accepted standards. TGA is responsibleto
provide a national framework for the regulation
of therapeutic goods in Australia so that the
performance of medical devices and the efficacy,
safety, and quality of medicines are
guaranteed.In essence, before they can be
supplied in Australia, therapeutic goods must be
listed on the Australian Register of Therapeutic Goods.
Role of TGA:
The TGA performs an overall control using five key procedures:
✓ Review and approval of registered items prior to their release on the Australian
market;
✓ Development, upkeep, and oversight of systems for listing medications;
✓ Manufacturer licensing in accordance with global GMP standards;
✓ Sample-based post-market monitoring, surveillance, reporting of adverse events, and
answering of public questions
✓ The evaluation of export-ready pharmaceuticals

WHO good practices for pharmaceutical quality control

laboratories
The WHO Good Practices for National Pharmaceutical Control Laboratories
recommendations were adopted by the WHO Expert Committee on Specifications for
Pharmaceutical Products in 1999.These guidelines include recommendations for the quality
management system that should be used for the analysis of pharmaceutical APIs, excipients,
and active pharmaceutical ingredients (APIs), to show that accurate results are produced.
Pharmaceutical quality control testing typically involves repeating tests on samples of APIs
or a small number of pharmaceutical products, whereas national quality control laboratories
are required to be able to handle a much wider range of pharmaceutical substances and
products and, as a result, must employ a wider variety of test methods.Quality control
activities such as sampling, testing of APIs, excipients, packaging materials, and/or
pharmaceutical products, stability testing, testing in accordance with specifications, and
investigative testing may all be performed by quality control laboratories, in part or in full.
The primary purpose of quality control in
the pharmaceutical industry is to test the
medications at different stages of
production to ensure that they can move
on to the next stage and are produced in
line with the rules and standards necessary
for human use.They must be tested in
several work areas to have full control
over the quality of the medication being
produced. The QC training module
consists of 4 parts, which are described below:
Part1:Management and Infrastructure
• Organization and management: The quality control laboratory should-
a) include managerial and technical staff that are empowered and equipped to do their
tasks and detect deviations from the quality management system.
b) have measures in place to ensure that its management and staff are not susceptible to
demands from the market, the government, the financial sector, or other interests that
could degrade the quality of their work
c) describe each employee's role, the scope of authority, and working connections
d) ensure the exact attribution of duties, especially when designating specific units for
certain categories of drugs
e) appoint those skilled in the test and/or calibration, validation, and verification
methodologies and processes to adequately supervise workers, including trainees
f) possess management that is in charge of the technical operations overall and is in
charge of providing the resources necessary to ensure the requisite standard of
laboratory operations
g) make sure there is adequate information flow among employees at all levels
h) assure the sample's traceability from receipt through all testing stages and the
completion of the analytical test report
• Quality
management
system: A quality
management system that
is appropriate to the
extent of the laboratory's
or organization's
activities, including the
type, range, and volume
of testing and/or
calibration, validation,
and verification activities
it does, should be
 established, implemented, and maintained. The administration of the laboratory
should make sure that all of its policies, systems, programs, procedures, and
instructions are adequately described so that the laboratory can guarantee the caliber
of the test findings it produces. The right individuals should be informed, given access
to, and trained to use the documents used in this quality management system. The
components of this system should be recorded for the organization as a whole and/or
for a laboratory within the organization.
a) The laboratory must create, carry out, and uphold legal written SOPs.
b) The laboratory's operations should be routinely audited to ensure compliance with the
quality management system's criteria and to implement corrective and preventive
actions, as needed.
c) Management reviews of quality problems should be conducted regularly.
• Control of documentation:A
major element of the quality
management system is documentation.
All documents that are a component of
the quality documentation should be
controlled and reviewed by the
laboratory using established and up-to-
date methods, both internally and from
other sources. Document distribution
and the current version status should be
listed in a master list that is easily
accessible.
• Records:
a) For the identification, collection, indexing, retrieval, storage, maintenance, disposal,
and access to all quality and technical/scientific records, the laboratory should
establish and manage processes.
b) All original observations should be kept on file for the proper amount of time, along
with any calculations, derived data, calibration, validation, and verification records,
and final results.
c) All technical and scientific documents must
be readable, easily accessible, preserved,
and retained in settings that offer an
atmosphere that will shield them from
alteration, loss, damage, or deterioration.
d) Records for quality management should
include reports from management reviews
and audits, both internal (and external, if
conducted) as well as all complaints and
their investigations, including records of potential remedial and preventive actions.
• Data-processing equipment:The laboratory should make sure the following
with regard to computers, automated test or calibration equipment, and the collection,
processing, recording, reporting, storage, or retrieval of test and/or calibration data:
a) The user's computer program has been sufficiently detailed documented and has been
verified or validated to be
fit for usage.
b) Data integrity is protected
by established and put-into-
practice procedures.
c) Computers and automated
equipment are kept in good
working order and are
given the operational and
environmental conditions
required to guarantee the
accuracy of test and
calibration data.
d) For making, recording, and
managing changes to the information held in computer systems, procedures are
established and put into practice.
e) According to an established process, electronic data should be backed up at suitable,
regular intervals.
• Personnel:
a) The laboratory should have enough employees who are qualified for their respective
roles based on their education, training,
technical expertise, and experience.
b) The technical management should make
sure that any employee using
specialized tools, instruments, or other
gadgets while conducting tests,
calibrations, validations, or verifications
is competent. In addition to signing
analytical test reports and certificates of
analysis, their duties also include
evaluating the results.
c) Employees who are undergoing training should be properly supervised, and afterward,
they should be evaluated. When necessary, specific duties should only be carried out
by personnel who are properly qualified in terms of their education, training, and
experience.
d) The lab staff should have a contract or be permanently employed. The lab needs to
make sure that any contracted additional technical and critical support staff is
adequately supervised, qualified, and doing work that complies with the quality
management system.
e) All staff members involved in tests, calibrations, validations, and verifications should
have up-to-date job descriptions, according to the laboratory. Additionally, the
laboratory must keep records of every member of the technical staff that details their
education, training, and experience.
• Premises:
a) The laboratory facilities must be in a proper location, size, and structure. These
facilities must be built to accommodate the uses and activities that will be carried out
there. Rooms for relaxation and refreshments must to be apart from scientific spaces.
The number of users should be
considered while designing changing
rooms and restrooms.
b) Adequate safety equipment should be
present in the laboratory facilities,
and proper housekeeping procedures
should be followed. The right tools
and equipment, such as
workbenches, workstations, and
fume hoods, should be present in every laboratory.
c) The surrounding environment, including the lighting, energy sources, temperature,
humidity, and air pressure, must be suitable for the tasks and activities to be carried
out. The laboratory should make sure that the surrounding environment is tracked,
managed, and documented and does not invalidate the findings or degrade the
accuracy of the measurements.
d) To handle, weigh, and manipulate highly toxic substances, particularly genotoxic
substances, special measures should be taken, and if necessary, a separate and
dedicated unit or equipment should be present. There should be procedures in place to
prevent contamination and exposure.
e) In order to ensure the safe preservation and retrieval of all documents, archive
facilities should be made available. The archives' layout and upkeep should be such
that they shield their contents from degradation. Only authorized people should be
allowed access to the archives.
f) Procedures for the secure disposal of different waste kinds, such as toxic waste
(chemical and biological), reagents, samples, solvents, and air filters, should be in
place.
• Equipment, instruments and other devices:
a) The design, construction, adaptation, location, calibration, qualification, verification,
and maintenance of equipment, instruments, and other devices should be done in
accordance with the operations that will be conducted in the local environment. The
equipment should be purchased from a vendor who can offer full technical support
and maintenance as needed.
b) For the proper execution of the tests and/or calibrations, validations, and verifications,
the laboratory should have the necessary test instruments, equipment, and other
devices.
 c) In addition to meeting the laboratory's standards and the applicable standard
specifications, equipment, instruments, and other devices, including those used for
sampling, should be routinely verified, qualified, and/or calibrated.
• Contracts:
➢ Purchasing services and supplies:
a) The laboratory should have a process in place for choosing and acquiring the
products and services it employs that have an impact on the testing's quality.
b) The laboratory should review suppliers of essential consumables, supplies, and
services that have an impact on the quality of testing, keep track of these
evaluations, and compile a list of approved vendors who have proven to meet the
laboratory's standards for quality.
➢ Subcontracting of testing:
a) A laboratory must cooperate with organizations that have been approved for the
kind of activity required for subcontracting work, which may include particular
testing. The laboratory is in charge of routinely evaluating a contracted
organization's proficiency.
b) When a laboratory conducts tests for a client and subcontracts some of the tests, it
should notify the client in writing of the arrangement and, if necessary, get their
agreement.
c) Written agreements that specify each party's obligations, the work to be performed
under contract, and any technical arrangements related to it should be made.The
agreement should allow the laboratory access to records and saved samples, as
well as the ability to audit the organization's capabilities and facilities.
d) Any work assigned to the contracted organization under the terms of the contract
should not be transferred to a third party without first receiving consent from the
laboratory.
Part2: Materials, equipment,instruments and other devices
• Reagents
All chemicals and reagents, such as solvents and materials utilized in tests and assays, have to
be of the proper caliber. Reagents should be bought from reliable, recognized vendors, and
they should come with the necessary material safety data sheets and certificates of analysis.
When preparing reagent solutions in the lab:
(a) responsibility for this task should be clearly specified in the job description of the person
assigned to carry it out; and
(b) prescribed procedures should be used which are in accordance with published
pharmacopeial or other standards where available. Records should be kept of the preparation
and standardization of volumetric solutions.
The labels of all reagents should clearly specify:
(a) content;
(b) manufacturer;
(c) date received and date of opening of the container;
(d) concentration, if applicable;
(e) storage conditions; and
(f) expiry date or retest date, as justified.
The labels of reagent solutions prepared in the laboratory should clearly specify:
(a) name;
(b) date of preparation and initials of technician or analyst;
(c) expiry date or retest date, as justified; and
(d) concentration, if applicable.
The labels for volumetric solutions prepared in the laboratory should
clearly specify:
(a) name;
(b) molarity (or concentration);
(c) date of preparation and initials of technician/analyst;
(d) date of standardization and initials of technician/analyst; and
(e) standardization factor.
Note: The laboratory should ensure that the volumetric solution is suitable for use at the time
of use.
In the transportation and subdivision of reagents:
(a) whenever possible they should be transported in the original containers; and (b) when
subdivision is necessary, clean containers should be used and appropriately labelled.
➢ Visual inspection
When they are brought to the store and when they are distributed to the units, all reagent
containers should be visually verified to make sure the seals are still intact. Reagents that
appear to have been tampered with should be rejected; however, in rare cases, this rule may
be relaxed if testing can validate the identification and purity of the reagent in question.
 ➢ Water
Water should be regarded as a reagent. When an authorized test is available, it should be
utilized to determine the appropriate grade for that test as specified in the pharmacopoeias.
During its supply, storage, and distribution, precautions should be taken to prevent
contamination. To guarantee that the various classes of water satisfy the necessary
requirements, the quality of the water should be constantly checked.
➢ Storage

Reagent supplies should be kept in a store under the proper storage conditions (ambient
temperature, under refrigeration or frozen). For transferring reagents from larger to smaller
containers, the shop should have an ample supply of clean bottles, vials, spoons, funnels, and
labels. For the transfer of higher quantities of corrosive liquids, specialized equipment could
be required. The store manager is in charge of maintaining the inventory, the storage
facilities, and keeping track of when chemicals and reagents expire. Getting trained may be
necessary to handle chemicals properly.
• Reference substances and reference materials
Reference substances (primary reference substances or secondary reference substances is
used for the testing of a sample.
Note: When accessible and suitable for the analysis, pharmacopeial reference materials
should be used. The maker should utilize its own reference compounds when a
pharmacopoeia reference substance has not been developed. For the calibration and/or
certification of equipment, instruments, or other devices, reference materials may be required.
➢ Registration and labelling
All reference compounds, with the exception of pharmacopoeial reference substances, should
be given an identifying number. For each new batch, a different identification number should
be given. The reference substance's vials should all have this number. Every time the
reference material is utilized in the analytical worksheet, the identification number must be
given. When using pharmacopoeial reference materials, the worksheet should be
accompanied with the batch number and/or batch validity declaration.
 The register for all reference substances and reference materials should be maintained and
contain the following information:
(a) the identification number of the substance or material;
(b) a precise description of the substance or material;
(c) the source;
(d) the date of receipt;
(e) the batch designation or other identification code;
(f) the intended use of the substance or material (e.g., as an infrared reference substance or as
an impurity reference substance for thin-layer chromatography);
(g) the location of storage in the laboratory, and any special storage conditions; (h) any
further necessary information (e.g. the results of visual inspections);
(i) expiry date or retest date;
(j) certificate (batch validity statement) of a pharmacopoeial reference substance and a
certified reference material which indicates its use, the assigned content, if applicable, and its
status (validity); and in the case of secondary reference substances prepared and supplied by
the manufacturer, the certificate of analysis.
To be in charge of reference products and reference materials, a person should be proposed.
A separate reference substances unit should be developed if a national pharmaceutical quality
control laboratory is necessary to create reference compounds for use by other institutions.
For reference substances prepared in the laboratory, the file should include the results of all
tests and verifications used to establish the reference substances and expiry date or retest
date; these should be signed by the responsible analyst.
➢ Retesting (monitoring)
To make sure that degradation has not taken place, all reference substances created in-house
or obtained from outside sources should be retested
periodically. The amount of time between tests relies
on a variety of elements, such as the substance's
stability, the storage conditions used, the kind of container, and the level of usage (how often
the container is opened and closed). In the WHO General guidelines for the establishment,
maintenance, and distribution of chemical reference substances, more specific instructions on
the handling, storing, and retesting of reference substances are provided. The accountable
analyst should note and sign the findings of these tests.

If retesting of a reference substance yields noncompliant results, a review of tests conducted

using the reference substance since its prior inspection should be conducted. Risk analysis
should be used to evaluate the results of retrospective inspections and take into account
potential remedial measures. Pharmacopoeial reference materials undergo routine retesting,
and the validity (current state) of these reference materials can be obtained from the
pharmacopoeia that issued them via a variety of channels, such as websites or catalogs. If the
reference chemicals are stored in accordance with the recommended storage conditions, the
laboratory does not need to conduct further testing.
• Calibration, verification of performance
When possible, each piece of apparatus, instrument, or other device used for calibration,
verification, or testing should be uniquely identifiable. The condition of calibration and the
date when recalibration is required should be shown on all equipment, instruments, and other
devices that require calibration, such as volumetric glassware and automated dispensers.
Design qualification, installation qualification, operation qualification, and performance
qualification should all be performed on laboratory equipment (for definitions of these terms
see the Glossary). Depending on the instrument's function and operation, the installation
qualification, operational qualification, and performance qualification of a commercially
available standard instrument may be regarded as sufficient indicators of its suitable design.
Specific procedures should be established for each type of measuring equipment, taking into
account the type of equipment, the extent of use and supplier’s recommendations. For
example:
— pH meters are verified with standard certified buffer solutions before use;
— balances are to be checked daily using internal calibration and regularly using suitable test
weights, and requalification should be performed annually using certified reference weights.
Equipment, instruments, and gadgets should only be used by authorized persons. A schedule
indicating the dates on which verification and/or calibration are required, as well as current
SOPs on the usage, maintenance, verification, qualification, and calibration of equipment,
instruments, and devices, should be easily accessible for use by the necessary laboratory
employees.
Records should be kept of each item of equipment, instrument or other device used to
perform testing, verification and/or calibration. The records should include at least the
following:
(a) the identity of the equipment, instrument or other device;
(b) the manufacturer’s name and the equipment model, serial number or other unique
identification;
(c) the qualification, verification and/or calibration required;
(d) the current location, where appropriate;
(e) the equipment manufacturer’s instructions, if available, or an indication of their location;
(f) the dates, results and copies of reports, verifications and certificates of all calibrations,
adjustments, acceptance criteria and the due date of the next qualification, verify cation
and/or calibration;
(g) the maintenance carried out to date and the maintenance plan; And
(h) a history of any damage, malfunction, modification or repair.
It is also recommended that records
should be kept and additional observations
made of the time for which the equipment,
instruments or devices were used.
Procedures should include instructions for
the safe handling, transport and storage of
measuring equipment. On reinstallation,
requalification of the equipment is required
to ensure that it functions properly.
It is important to develop maintenance protocols, such as having a team of maintenance
experts—internal or external—perform routine service, which is then followed by
performance evaluation. Equipment, instruments, and other equipment that have been
misused or overloaded and have produced findings that are questionable, evidently flawed, or
outside of acceptable bounds should be removed from service and prominently tagged or
labeled. They ought to be fixed and requalified before being utilized, if at all feasible.
The laboratory should requalify the equipment to guarantee its acceptability for use when the
equipment, instruments, and other devices are beyond the direct supervision of the laboratory
for a set amount of time or have undergone significant repair.
Note: For further guidance on calibration, verification of performance and qualification of
equipment refer to:
• The International Pharmacopoeia contains procedures for calibrating and verifying
refractometers, thermometers for calculating melting temperatures, potentiometers for
calculating pH, and ways to check the accuracy of scales for spectrophotometers that measure
ultraviolet and infrared light and spectrofluorometers.
• Specific guidelines for qualification of equipment elaborated by the European Network of
Authorized Medicines Control Laboratories
(OMCL) and
• General chapter of the US Pharmacopeia on Analytical instrument qualification.
 • Traceability
The result of an analysis should, where applicable, be traceable to a main reference material.
Any qualification or calibration of an instrument should be able to be tracked back to
accepted reference materials and SI units.
Part3: Working Procedures
• Incoming samples: A laboratory could receive samples for an investigation or for
compliance testing. It is crucial to work closely with the sample suppliers. It is vital
that the sample be big enough to allow for several replicate tests to be run.
Various sources, such as customs, police, and
medicine inspectors, may submit samples for
investigative testing. To positively identify the
drug or ingredient(s), there should be well-
documented screening methods in place. If a
content estimate of a certain chemical or
ingredient is needed, a suitable quantitative
analytical approach should be used.
In order to submit a sample to the lab, it is
typical to divide it into three sections that are
approximately similar in size:
✓ one for immediate testing,
✓ one for confirmation of testing, if necessary,
✓ And one for storage in the event of a dispute.
All lab workers and analysts should have access to a sampling strategy and internal procedure
for sampling. Samples must be obtained from batches of material that are typical of those
batches, and they must be handled carefully to prevent contamination, other quality-affecting
factors, and material mixing.
• Test request: For each sample that is delivered to the lab, a standard test request
form needs to be filled out and included. In the event of a laboratory run by a
pharmaceutical company, the criteria can be specified in the master production
instructions.
• Registration and labelling: A registration
number should be assigned to recently delivered
samples and any supporting documentation. For
requests involving two or more medications,
various dosage forms, or various lots of the same
medication, distinct registration numbers should
be given. Each container holding the sample
should have a label attached with the registration
number. It is important to take care not to cover up
 any further inscriptions or marks.
The following details should be documented in a register, which might be a record book, a
card file, or a piece of data processing technology:
➢ The sample's registration number;
➢ The date of receipt;
➢ The specific c unit to which the sample was forwarded.
• Visual inspection of the submitted sample: The labeling on samples should be
examined by laboratory personnel to make
sure that it matches the data on the test request
form. Inconsistencies should be noted and
reported right once, as should any visible
sample damage. Any questions should be sent
back to the sample's originator.

• Storage: The sample prior to testing, the

retained sample, and any portions of the
sample remaining after performing all
needed tests should be stored properly,
taking into account the sample's storage
circumstances.
• Forwarding to testing: Sample examination should not begin until the required test
request is received, and samples should be carefully stored until all applicable
documentation is received.
• Analytical worksheet: The analytical worksheet is an internal document used by the
analyst to record information about the sample, the test technique, computations, and
testing findings. It will be complemented with the raw data gathered throughout the
analysis.
Purpose: The analytical worksheet comprises documentation evidence that either:
• confirms that the material being investigated meets the standards;
• Or supports an OOS result.
Use:
➢ A separate analytical worksheet should be utilized for each numbered sample or group
of samples.
➢ Analytical worksheets from multiple units referring to the same sample should be
combined.
• Selection of the specifications to be used: The specification required to assess the
sample may be found in the test request or master production instructions. If no
specific instructions are given, the specification in the officially recognized national
 pharmacopoeia or, failing that, the manufacturers officially approved or other
nationally recognized specification may be utilized. If no acceptable approach is
available:
The specification contained in the marketing authorization or product license may be
requested from the marketing authorization holder or manufacturer and verified by the
laboratory; or the requirements may be set by the laboratory itself based on published
information, and any procedure used must be validated by the testing laboratory.
Filling: The analytical worksheet, together with any attachments, such as computations and
recordings of instrumental analyses, should be maintained carefully.
• Validation of analytical procedures
All analytical processes used for testing must be appropriate for the intended usage.
Validation demonstrates this by establishing acceptance criteria for system suitability testing.
Validation should be carried out in accordance with a validation process that contains the
analytical performance criteria to be validated. The following table lists typical qualities that
should be evaluated:

System suitability tests are used to verify pharmacopoeial or approved analytical methods.
The equipment, electronics, analytical processes, and samples to be analyzed all contribute to
the system. If a significant number of samples are being analyzed in succession, relevant tests
must be done throughout the series to establish that the technique is adequate.
 • Testing
The sample should be maintained in a secure location so that it does not interfere with other
laboratory examinations. If this is not feasible, the reasons for this may be documented, for
example, in the analytical worksheet, and the sample kept in such a location.
It may be necessary to make arrangements for the transport of the requisite number of units
(bottles, vials, or tablets) to test a patient's blood sample to another laboratory. These units
should all have the appropriate registration number. The findings of tests carried out by
subcontractors should be recognized in the analytical test report as coming from the
subcontracted laboratory.
To enable suitably qualified analysts to do the analysis, test methods should be outlined in
depth and give enough information. Any variation from the test protocol needs to be
authorized and recorded.
• Evaluation of test results
After all the tests are finished, the test results should be examined and, if necessary,
statistically analyzed to see whether they are mutually
consistent and if the requirements were met. When skewed
(atypical) findings are discovered, they should be looked
into. In accordance with the internal quality management
system, the entire testing process must be reviewed.
Only if a clearly identified mistake is to blame may
doubtful results be discarded. A retest of the sample is
required when an investigation's findings are inconclusive.
An OOS result would be indicated by a value of this kind;
however additional confirmation using a different
approved approach would be suggested.
The maximum number of retests should be specified in a SOP (based on sound statistical
principles). Reporting should include the acceptance criteria for every individual outcome (all
test data). Any remedial actions and preventative measures should be documented and put
into place in the case of a mistake.
• Analytical test report: The analytical test report includes a summary of the findings
and the findings of the examination of a sample. It must be given by the lab and be
based on the analytical worksheet. An analytical result should have its production
capacity and acceptability standards defined in advance.
There are several ways to estimate measurement uncertainty, including –
➢ creating an uncertainty budget for each uncertainty component identified in an
analytical procedure (bottom-up approach);
➢ using validation data and control charts;
➢ And using information from proficiency tests or collaborative trials (top-down
approach).
 • Certificate of analysis
Each batch of a chemical or product has a certificate of analysis generated for it that typically
includes the following details:
(A) the sample's registration number;
(B) the receipt date;
(C) the laboratory testing the
sample's name and address;
(D) The contact information for the
person who submitted the
request for analysis;
(E) the sample's name, details, and
batch number, when applicable;
(F) the brand name and address of
the original producer as well as,
if relevant, the reseller and/or
trader;
(G) a mention of the specification
that was used to test the sample;
(H) the findings of each test (with the
mean and standard deviation, if
appropriate) within the
established bounds;
(I) a determination of whether the sample was discovered to be within the parameters of
the specification;
(J) expiry date or retest date if applicable;
(K) date on which the test(s) was (were) completed;
(L) and the signature of the head of laboratory or other authorized person
• Retained Sample:
According to the law or the person who made the first request for analysis, samples must be
kept on file. In order to allow for at least two re-analyses, there should be enough retained
sample. Retaining the sample in its original packaging is recommended.
Pharmaceutical quality
As in most assembling processes, the nature of a last drug still up in the air by the beginning
materials, gear, and specialized skill that go into creating and bundling it. The reason for
quality confirmation in drug supply frameworks is to assist with guaranteeing that each
medication arriving at a patient is protected, compelling, and of suitable quality.
Pharmaceutical quality assurance framework
The accompanying five components are basic to accomplishing the normal treatment result.
Utilizing a drug item to treat a patient assumes that the —
1. Active drug fixing (Programming interface) has been demonstrated to be protected and
powerful for this treatment
2. Product is of reasonable quality to give a powerful result
3. Prescriber has precisely distinguished the requirement for the treatment

Source: CPM/MSH 2011.

4. Prescriber or distributor has appropriately taught the patient the most proficient method to
utilize the item
5. Patient consents to the recommended routine accurately

Defining and assessing pharmaceutical quality

Drug quality can be characterized and tried in numerous ways. Quality principles are
distributed occasionally in pharmacopeias and in some administration distributions, which
give point-by-point depictions of drug attributes and logical techniques for drug obtainment
associations, drug quality is surveyed as the item's consistency with details concerning
personality, virtue, strength, power, and different attributes
Personality.
The character test ought to affirm the presence of the dynamic ingredient(s) shown in the
name.
Immaculateness.
Notwithstanding the Programming interface, most drugs are made with fixings added for
mass, consistency, or variety that shouldn't contain possibly unsafe impurities or
microorganisms. The item shouldn't have huge amounts of different items from cross-
pollution.
Strength or power.
Hurtful side-effects of corruption should be missing or underneath characterized limits. Most
pharmacopeias determine a typical substance range, for example, 90 to 110 percent of the
sum composed on the name. To guarantee a long timeframe of realistic usability, makers
frequently produce drugs with the most extreme permissible sum.
Consistency of dose structure.
The consistency, variety, shape, and size of tablets, cases, creams, and fluids shouldn't change
starting with one portion and then onto the next. The absence of measurement consistency
may not impact the security or viability of medication, however, it mirrors a lack of good
assembling rehearses.
Bioavailability.
Bioavailability alludes to the speed and fulfillment with which a drug managed in a particular
structure (tablet, case, intramuscular infusion, subcutaneous infusion) enters the circulation
system. The bio-accessibility of an item might rely upon different fixings utilized in the
detailing. Two drugs are supposed to be bioequivalent assuming they are assimilated into the
circulation system at a similar rate and similarly. Human bioequivalence reads are expected
for various medications. The Biopharmaceutical Arrangement Framework can assist with
recognizing potential bioavailability issue items.

Some substances exhibiting potential bioavailability problems in conventional oral forms

Digoxin Carbamazepine

warfarin Chloroquine

levodopa

L-thyroxin

Stability
A pharmaceutical's stability depends on its active ingredient, which can be affected by its
formulation and packaging. Improper storage and distribution can lead to physical
deterioration and chemical decomposition. These effects are more likely to occur under
tropical conditions of high temperature and humidity.

Medicine found stability problem under tropical or high-temperature conditions

Tablet syrup Inhaler

Penicillin V Paracetamol Ipratropium

Retinol

Amoxicilline

Environmental effect
A few items might go through physical or synthetic changes that can bring about conceivably
harmful corruption items. Antibiotic medication is the main normal medication wherein it is
known to happen. Defilement of creams, syrups, and different prescriptions in containers and
cylinders is particularly normal in tropical conditions.
Insufficient consideration or the need to treat antagonistic medication responses coming
about because of unfortunate item quality prompts more exorbitant medicines. Unfortunate
drug bundling projects questions on push uct quality, prompting dismissal by wellbeing
faculty and patients. These items will then, at that point, lapse on the clinical stores' racks,
squandering restricted monetary assets
Poor pharmaceutical quality may seriously affect health system credibility.
Patients and suppliers might associate the quality with medications when remedial
disappointment or unfavorable medication responses happen. Changes in item appearance,
like staining, disintegrating of tablets, and solidifying of oral suspensions, or changes in taste
and smell properly impact patients' impression of item quality. Patients might be discouraged
from utilizing wellbeing offices, and specialist assurance might be impacted, especially
assuming medication deficiencies are likewise normal.
Determinants of pharmaceutical quality:
The nature of a medication item falling off the creation is not entirely set in stone by the
beginning of materials, plant environment, producing hardware, and specialized expertise put
resources into creating and fabricating the drug. The medication that at last arrives at the
patient is additionally impacted by bundling and by transportation and capacity conditions.
Practical approaches to quality assurance
The methodology to lay out a far-reaching quality confirmation program can be partitioned
into three classifications —
1.Procedures to guarantee that main medication items that fulfill current guidelines for
quality are purchased. These incorporate —
• Cautious provider choice
• Declaration of investigation for each cluster of item
• Certificate of good assembling rehearses
• Cluster certificate (WHO-type testament of a drug item)
• Consideration of point-by-point item quality determinations in the agreement
2.Procedures to check that delivered merchandise meet the determinations. These
incorporate:
• Pre-and post-shipment assessment
• Scientific drug testing
3. Procedures to screen and keep up with the nature of drugs from the second they are gotten
until the medication is at long last consumed by the patient. These include —
• Legitimate capacity and appropriation strategies
• Fitting apportioning
• Guidelines to the patient on the appropriate utilization of prescriptions
• Item deformity and pharmacovigilance revealing projects

4.The selection of meds to screen intently depends on the accompanying rules —

• Meds with a thin remedial window
• Meds with inborn bioavailability issues
• Altered discharge arrangements
• Items from new providers and providers with issues previously
• Medications that require stable measurements structures and appearance

Critical elements in quality assurance for pharmaceutical procurement

1.Product selection
• products with longer shelf life
• avoidance of products with bioavailability problems, when possible
2.Product certification(supplier)
 • supplier prequalification
• recent GMP inspection reports from national drug authorities
• formal supplier-monitoring system
• limitation of purchases from new suppliers to noncritical products
3.Product certification
• GMP certificate from drug regulatory authority
• certificate of pharmaceutical products (WHO-type) for all new products, new
suppliers
• batch certificate (WHO-type) for problem drug
4.Contract specification
• acceptable pharmacopeial standards
• language, labeling requirements
• minimum shelf life
• packaging standards
5.Inspection of shipments
• physical inspection of all shipments
• sampling for analysis of suspect products
6.Targeted laboratory testing
• therapeutically critical drugs
• drugs with known bioavailability problems
• new suppliers
Supplier selection
Providers can be chosen seriously by limited delicate with prequalification or open delicate
with post-award capability. Standard systems ought to incorporate requiring accreditations,
and gathering data on provider dependability, and item quality. Tracking the state of gotten
goods, compliance with contract terms, and practicality of conveyance is fundamental.
Product certification:
WHO has laid out GMPs for drug items, like those implemented by public drug control
offices in industrialized nations. GMPs incorporate rules for staff, offices, gear, materials,
producing tasks, naming, bundling, quality control, and soundness testing. Purchasers with
drug staff prepared in GMP reviews might play out their own assessments of nearby
providers. This certificate conspire gives some affirmation, in view of the assessment of the
assembling offices for GMPs by the able power of the trading country. through the
confirmation plot, the acquisition office ought to have the option to acquire the
accompanying data —
• Whether an item is legitimately promoted in the sending out country, and on the off chance
that not, the motivations behind why
 • Whether the provider produces the measurement structures, and bundles potentially names
a completed dose structure manufactured by a free organization, or is engaged with none of
these exercises
• Whether the producer of the item has been reviewed and the periodicity of investigation
• Whether the testament is temporary, the forthcoming technical survey
• Whether the data put together by the provider fulfills the guaranteeing expert on all parts of
assembling the item attempted by another party
The unwavering quality of the drug item declarations given under the WHO plan and
admittance to them rely to a great extent upon the —
• Dependability and responsiveness of the trading coun-attempt's position
• Ability of the trading country's position to make sufficient GMP assessments
• Capacity of the bringing in country's position to evaluate the legitimacy or legitimacy of
the testament of a drug item submitted, particularly when it is submitted through the producer
or bringing in specialist

Product pedigrees
Drug wholesalers who give deceitful or no-item families might assist with redirecting
counterfeits into genuine appropriation frameworks. The inability to follow family necessities
is illegal in the US. Electronic following is logically more productive and secure, yet it
requires costly innovation and preparation.
Batch certificates
Solid drug makers might agree with GMPs by regularly directing cluster examinations.
Nearby manufacturers that don't have their own quality-control laboratories might contract
quality-control testing administrations from different producers, confidential testing offices,
or public reference laboratories. Some drug acquisition workplaces demand different
testaments, like the authentication of the free deal, the certificate of beginning, or the
declaration of permitting status
Contract specifications
Point-by-point determinations to assist with guaranteeing that great items are purchased and
gotten incorporate the accompanying —
• Logical strategies and wellspring of reference materials or archived proof of
reasonableness for the material used to evaluate item quality credits and endorsement
of examination.
• Language for the item name and bundle insert,which ought to be the language or
dialects normal to the country.
• Least data expected on the mark (conventional or Global Nonproprietary Name,
measurements structure, strength, amount, termination date, producer, clump number)
• Extra data, for example, the item enlistment number and date of assembling.
 • Principles for bundling that will endure the particular stockpiling and transport
conditions (for instance, folded boxes with determinations for dividers, most extreme
size, and greatest weight).
Maintaining pharmaceutical quality
Maintaining medicine quality requires careful attention to storage conditions and transport, as
well as to dispensing practices and use.
A.Storage conditions:The labeling, which is based on the findings of stability testing, should
be followed when determining the storage conditions for materials and medicinal goods. To
guarantee that the necessary storage conditions are maintained, heating, ventilation, and air
conditioning systems (HVAC) should be properly planned, installed, qualified, and
maintained. Temperature and relative humidity levels should be managed and checked on a
regular basis, as necessary.
B. Crucial Factors for Transporting Pharmaceutical Products
1. Concerns with cargo temperature: Pharmaceuticals must be transported at a specific
temperature to maintain their safety and effectiveness. Even though medications must be
transported at a higher temperature than food and beverages, especially frozen foods, it is still
crucial to maintain the temperature of the cargo.
2, Cold Chain Active: The term "active cold chain" refers to a truck's internal cooling
systems that are intended to maintain a constant temperature throughout the cargo
compartment. The superior choice for temperature-sensitive goods like pharmaceuticals is
active cold chain transportation.
3. Passive Chain of Cold: When you order meat online, you receive a passive cold chain,
which consists of Styrofoam or polystyrene packaging and ice or dry ice to keep the food
chilled.
4. Tracking and Monitoring of Temperature: During transit by truck, ship, air, or some
other logistical operation, the ambient atmospheric temperature varies greatly depending on
the shipment area.
5. System Versatility: Make sure the procedure may be altered to meet your needs, taking
into account integration with both your current office setup and your client's office systems.
Such dynamic integrations reduce manual entry for you and your clients, shorten wait times,
and eliminate phone calls for email checks, allowing you to work more and offer your
competitors very distinctive customer care.
Appropriate dispensing and use
The deterioration and contamination of pharmaceutical products as well as medication errors
are caused by improper dispensing practices. The subsequent steps aid in maintaining the
caliber of pharmaceutical goods. Use only appropriate dispensing equipment. For end-user
dispensing, paper envelopes are frequently utilized, although they do not safeguard tablets
and capsules. Assert policies to mark products with the patient's name, the medicine's name,
its strength, its expiration date, and instructions for use and storage. Clear labeling of
prescribed medications is a must. Avoid using abbreviations when writing directions and
information, or use symbolic language instead. When dispensing medications, the dispenser
and the prescriber should instruct the patient on how to use them properly, explaining what
the medication is, why the patient needs it, how to take it, and where and how to store it until
the patient receives
Monitoring pharmaceutical quality
Despite every precaution, occasionally defective products get through, and even the best-
made products can lose quality. Additionally, both patients and health care professionals may
mistakenly believe that only name-brand products from innovator corporations have high
product quality, particularly in cases when generic drugs are not widely known and approved.
❖ Monitoring of storage conditions
• It should be possible to review the temperature monitoring data that was recorded.
• The monitoring apparatus should be examined at appropriate, predefined intervals, and the
findings of such examinations should be documented and kept.
• All monitoring data should be retained for at least the amount of time the product or
substance is held plus one year.
• Where applicable, temperature mapping should demonstrate temperature homogeneity
across the storage facility.
• Monitoring equipment needs to be calibrated on a regular basis.
❖ Product problem reporting system
It's critical to establish a national mechanism for reporting product issues so that medical
professionals can report alleged or verified issues with particular pharmaceutical products. A
comprehensive pharmacovigilance system, which also includes monitoring and reporting
adverse drug events and prescription errors, should include the reporting of product problems.
What additional steps need to be taken, such as sending samples or information about the
quantities involved, how to fill out the reporting form, where and to whom the reporting form
should be sent, what additional measures need to be taken, and what follow-up information
needs to be given to the person or facility that reported the problem. The employees of the
quality assurance program should carefully analyze each report, including laboratory testing
as necessary, and then take the necessary action. The
❖ Product recalls
Any faulty pharmaceutical items should be recalled right away. The country's DRA's quality
assurance section needs to create standardized processes for performing the recall. Once the
issue has been identified, quick action helps prevent needless exposure. The inventory control
system of the central distributor shall have information on all batches received. Recall notices
must be sent to all health facilities that received any of the recalled products in order to check
their shelves and return the products to the central distribution point because tracking
individual batches to the health facility is frequently either impractical or fraught with
uncertainty.
Recalls can be categorized based on how much of a risk there is for the consumer: A fatality
or serious disease, a brief or minor illness.Other contract-mandated remedies, such as
withholding payment or securing reimbursement for or replacement of the defective goods,
should be pursued by the procurement office. The quality assurance program should keep
track of the recall's development after it is issued to ensure full compliance.
Personnel and training in the supply system
At least one qualified pharmacist with experience in industrial pharmacy and procurement is
essential to the operation of the majority of well-run pharmaceutical supply systems. Such a
person can be quite helpful in developing and managing quality-control procedures that are
appropriate for local needs. This individual should take part in Determining the technical
requirements for pharmaceutical contracts storage and transportation facilities, choosing
suppliers, and evaluating supply offers. Coordinating any pharmaceutical quality tests and
assisting with inspector training. To assess whether dose, packaging, and labeling
requirements have been satisfied, pharmaceutical inspectors must possess a sufficient level of
familiarity with pharmaceutical labeling and packaging materials. To recognize the categories
of pharmaceuticals requiring particular storage and transit circumstances, port-clearing
employees should get training. At all tiers of the healthcare system, quality assurance is a
shared responsibility.

Pharmaceutical product presentations: treatment kits, co-packaging, and fixed-dose

combinations. Medicines can be packaged according to therapeutic regimens or for delivery
to dispensing sites or individual patients to facilitate and reduce the costs of inventory
management and distribution systems. For example, a tuberculosis treatment kit could
include enough anti- microbial products for a particular number of patients. Broader-based
treatment kits for poorly served areas may include a selection of essential medicines that
supplements the national supply system.To make inventory management and distribution
simpler and less expensive, medications might be packaged for delivery to dispensing
locations, individual patients, or therapy regimens. A tuberculosis treatment kit, for instance,
might contain adequate anti-microbial products for a specific number of patients. The
national supply system may be supplemented with broader-based treatment kits for
underserved areas that comprise a variety of important medications. Pharmaceutical
inspectors must be sufficiently versed with pharmaceutical labeling and packaging to
evaluate if dose, packaging, and labeling requirements have been met. Port-clearing
personnel should get training to recognize the categories of medications requiring specific
storage and transit conditions.Pharmaceutical product demonstrations, including co-
packaging, fixed-dose combinations, and treatment kits.

Verifying the quality of shipped products

You should thoroughly inspect your purchases before they are delivered to you in order to
find any potential flaws before the package gets to you. This will help you by cutting down
on the time it takes to rework the product and get the desired items, as well as by saving you
money on transportation costs (when shipping the products back for rework). There are
several options open to you when it comes to successfully examining the product's quality
before shipment. Let's examine some of the most popular techniques available to you and
decide which one would be most effective for you.
The 4 ways of checking product quality before shipment
1.Inspections by an external inspector(s) in the warehouse. This is the most common type of
quality inspection service: A random selection of products is examined to see if they fulfill
your requirements for other criteria and the product specifications. A third-party quality
control team is typically used by importers; using in-house QC staff is a less usual alternative.
Depending on whether the products match the requirements you gave the supplier, you may
decide to accept or reject the shipment.
2.Final inspections on sales orders by packer: The most frequent type of inspection for large
shipments is this one. especially from nations that engage in a lot of commerce, like Japan.
Using this technique, the products are sent to a certain platform. like a storehouse for
forwarders. where a space is booked so that the inspection can be conducted. Depending on
the requirements of the importer, the inspection may be performed on a portion of the entire
consignment.
3.Piece-by-piece inspection in the warehouse by checking and packing person: If you want to
check every piece of the cargo carefully. Then a piecemeal strategy is what you should
choose. In essence, this entails establishing an inspection location apart from the supplier's
staff. however is present on-site to check each finished product.
4.Clean all product before shipping to customer, insure to that the product is clean and ready
to use by end customers: This is likely the least typical strategy used by importers and works
best in extremely specific situations. You've been using the supplier's products for a while.
More than 30% of the factory's output is being purchased by you. And you have great faith in
their moral character and honesty.

Conclusion:
● To maintain or enhance the quality of the offerings, manufacturers use two
techniques, quality control and quality assurance.
● These two practices make sure that the end product or the service meets the quality
requirements and standards defined for the product or the service.
● Therefore, for achieving national and international accreditation quality control and
quality assurance activities should be performed properly.
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