Heliopolis University

Faculty of Pharmacy
Quality Control of
Pharmaceuticals
Code : PC 011
By
Dr. Ragab Ahmad Said
 Quality
• The quality of a product or service refers to the perception of the degree to
which the product or service meets the customer's expectations.

• In pharmaceutical practice; quality means that a product to be handled should

be safe and effective.

Pharmaceutical industry needs well established production units for all

different dosage forms. The quality of medicinal and related products is the sum
of all factors which contribute directly or indirectly to the safety, efficacy and
acceptability of the product.
 Quality meanings:
Quality is a measure of excellence or a state of being free from defects, deficiencies
and significant variations.

• According to ISO:

Quality is the degree to which a set of inherent characteristics fulfills requirement.

• Degree: Refers to a level which a product or service satisfies. So, depending on the
level of satisfaction, a product may be termed as excellent, good or poor quality
product.
• Inherent characteristics: Those features that are a part of the product and are
responsible for achieving satisfaction
• Requirements: Refers to the needs of the customer, needs of the organization, and
those of other interested parties e.g. regulatory bodies.
 Why Quality is important in pharmaceuticals?
• The pharmaceutical environment today is changing quickly due to globalization,
increased competition, demands for efficiency.
• To manufacture & deliver consistently zero-defect products to the patients.
As poor quality medicines:
• Are a health hazard.
• Waste money for governments and consumers.
• May contain toxic substances that have unpredictable, unintended consequences.
• Will not have a desired therapeutic effect.
• Harm everyone (patients, health care workers, policy makers, regulators,
manufacturers).
 Concepts of drug quality control
• Revealing control: The old concept of quality control was based on inspection i.e.
separation good products from bad ones with no feedback to the production process.

• Preventive control: The modern concept concerns with building in quality into the
product during the production process.
• In the modern concept, quality is the collective responsibility of every individual in an
organization from top management to the lower levels of management.
• This appeared with introduction of the guidelines of good manufacturing practices
(GMPs), in-process control (ICP) and validation of all processes involved (QA).
• The pharmaceutical industry adopted the broad concept of quality management which
means: building in quality, maintain it and continuously improving it. This was being
approached through the concept of Total quality management (TQM).
 I. Total quality management (TQM)
• Total ---- The involvement and the input of everyone
• Quality ----Fully meeting customers' needs and requirements all the time
• Management ---- The way we act, operate control and handle it.
• TQM is overall control involving quality assurance, GMP and quality control to
ensure the consumer receives good quality of product for its intended use and do not
place the health of the patients or consumers at risk due to inadequate safety and
quality.
• - According to ISO, (TQM) is " a management approach for an organization, centered
on quality, based on the participation of all its members and aiming at long-term
success through customer satisfaction and benefits to all members of the organization
and to the society".
1. COMMITMENT: All employees of the organization must have quality improvement
commitment.
2. CULTURE: Organization must develop and follow a modern culture for quality
improvement on a regular basis.
3. CONTINUOUS IMPROVEMENT: There must be continuous improvement in all policies,
procedures and activities laid down by top management for the company.
4. COOPERATION: Cooperation among employee and experience of employees must be
utilized for improving strategies and enhancing performance.
5. CUSTOMER: For long-term survival of the business, organization must focus on
customers' requirements and satisfaction of their expectations.
6. CONTROL: There must be effective control for monitoring and measuring the real
performance of the business.
The ultimate goals of TQM in pharmaceutical industry are to assure that:
• The drug product contains the labeled amount of the active constituent(s), within
the accepted limits.
• Each ingredient (active or inactive) used to formulate the finished product is of
suitable purity.
• The variation of drug levels between dosage units is minimized
• Each finished dosage form is of the highest possible purity, that is no contaminants
have entered during manufacturing process.
• The ingredients in the finished dosage form are stable, both individually and in the
presence of each other.
• The finished product is therapeutically effective.
 Steps of TQM
• “Deming Cycle” or “Shewhart Cycle” or “Deming Wheel”
• It describes a simple method to test information before making a major decision.
• It is an iterative 4-step problem-solving process called PDCA “Plan – Do – Check
(study) – Act”
• PLAN: Establish the objectives and processes necessary to deliver
results in accordance with the specifications.
• DO: Implement the processes (like the chemical analysis).
• CHECK (STUDY): Monitor and evaluate the processes and results again
to objectives and specifications and report the outcome.
• ACT: Apply actions to the outcome for necessary improvement.
• This reviewing all steps (Plan, Do, Check, Act) and modifying the process
to improve it before its next implementation.
II- Quality assurance (QA): which is the prevention of defects.
Quality assurance (QA) is the sum total planned and systematic actions necessary to obtain
confidence that the required quality of medicinal products is satisfactory for their intended use.

QA is a way of preventing mistakes and defects in manufactured products and avoiding problems when
delivering products or services to customers.
 III- Good manufacturing practice (GMP)

GMP is a part of QA which assures that products are consistently produced

and controlled to the quality standards appropriate for their intended use
and meet the legal requirements.
• GMP covers all aspects of manufacture including collection, transportation,
processing, storage, QC & delivery of the finished product.
• All manufacturing processes are clearly defined and systematically reviewed.
• GMP ensures that quality is built into the organization & processes involved in
manufacture.
 Why GMP is important?
As GMP is designed to minimize risks involved in any pharmaceutical production
It decreases the risks of:
• Contamination of products (microbial, particulate or other).
• Cross contamination
• Incorrect labels on containers.
• Insufficient active ingredient.
• Excess active ingredient.
• Poor quality raw materials.
• Poor formulation practices.
 The basic requirements of GMP are :
✓ Clear, written and approved instructions and procedures.
✓ Well-trained operators.
✓ Correct handling of starting/packaging materials.
✓ Correct materials, containers and labels.
✓ Suitable equipment and services.
✓ Proper storage and transportation.
✓ Records of actions e.g. (SOP).
• Standard operating procedure (SOP) is "an authorized written procedure giving
instructions for performing operations not necessarily specific to a given product or
material (e.g. equipment operation, maintenance and cleaning; validation and
environmental control; sampling and inspection).
 IV- Quality control (QC): is the detection of defects.

QC is the operational laboratory techniques & activities used to fulfill the requirement of
quality.

QC is a part of GMP concerning with sampling, specifications & testing and with organization,
documentation and release procedures which ensure that the necessary and relevant tests
are actually undertaken and the materials are not released for use, or products for sale or
supply, until their quality has been specified and justified to be satisfactory.

• QC is a set of activities for ensuring quality in products. The activities focus on identifying

defects in the actual products produced.

• The goal of QC is to identify defects after a product is developed and before it's released
• Responsibilities of QC in Pharmaceutical industry
✓ Raw, intermediate and packaging materials.
✓ Finished product analysis.
✓ Analytical method development and validation.
✓ Carrying out sampling and testing of materials or products.
✓ Environment monitoring.
✓ Conducting stability studies.
✓ Evaluation of complaint samples related to the quality of the product.
✓ Sufficient samples of starting materials and products must be retained to permit
future examination.
✓ To ensure that no materials or products will be released for sale or supply, until their
quality have been evaluated and judged to be satisfactory.
 Relation between GMP, QC, QA and Quality management:

• QA is the sum total of the organized arrangements with the objective of ensuring that

products will be of the quality required for their intended use.

• GMP is that part of QA aimed at ensuring that products are consistently

manufactured to a quality appropriate to their intended use.

• QC is that part of GMP concerned with sampling, specification & testing,

documentation & release procedures which ensure that the necessary & relevant

tests are performed & the product is released for use only after ensuring its quality.

• So, QC is the part of GMP and GMP is part of QA.

 TQM deals with
• Establishing a customer focused organization.
• Analyzing and improving work processes to improve efficiency and reduce
waste.
• Designing and establishing quality in products and processes.
• Providing training and placing emphasis on lifelong learning.
• Providing a leadership style of management which supports and cultivates the
one-team approach.
• Using statistical methods and other tools to analyze and solve problems,
identify solutions and measure improvement.
• Encouraging new ideas and rewarding success.
• Creating a structure and climate which reinforces quality improvement and
customer service.