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Basic Concepts of QA $ QC

The document outlines the concepts of Quality Control (QC) and Quality Management (QM) in the pharmaceutical industry, emphasizing the importance of quality assurance (QA) in ensuring product safety, efficacy, and compliance with standards. It details the responsibilities and objectives of QA and QC, highlighting their roles in maintaining high-quality outputs and customer satisfaction. Additionally, it distinguishes between QA as a proactive process focused on preventing defects and QC as a reactive process aimed at identifying and correcting defects in products.

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0% found this document useful (0 votes)
5 views25 pages

Basic Concepts of QA $ QC

The document outlines the concepts of Quality Control (QC) and Quality Management (QM) in the pharmaceutical industry, emphasizing the importance of quality assurance (QA) in ensuring product safety, efficacy, and compliance with standards. It details the responsibilities and objectives of QA and QC, highlighting their roles in maintaining high-quality outputs and customer satisfaction. Additionally, it distinguishes between QA as a proactive process focused on preventing defects and QC as a reactive process aimed at identifying and correcting defects in products.

Uploaded by

ftthmthrainh
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Quality Control

and
Quality Management
concepts
What is Quality ?
 Quality of a pharmaceutical  Freedom from defects
product is measured by it's  Degree of excellence
fitness for intended use.
 Safety and efficacy are part of  Customer/Buyer's satisfaction
quality.  Compliance with specified/official
requirements
Efficacy

Safety
Quality

QA/ 4
QC
What is Quality Management?
 WHO Definition :
 The aspect of management functions that determines and
implements the 'quality policy'
 Responsibility - To make a good quality of pharm. product
 Product must comply with basic requirements
 Identity

 Strength/ potency

 Purity

 Bioavailability and Biopharmaceutical parameters

 Basic Elements of QM
 Quality system infrastructure & systematic actions

6
RELATIONS IN QUALITY SYSTEMS
QUALITY ASSURANCE (QA)
According to WHO, quality assurance is a wide-ranging concept
covering all matters that individually or collectively influence the
quality of a product.
With regard to pharmaceuticals, quality assurance can be divided
into major areas: development, quality control, production,
distribution, and inspections.
ISO 9000 defines QA as "part of quality management focused
on providing confidence that quality requirements will be
fulfilled"
CONCEPTS OF QA

 QA is a set of activities for ensuring quality in the processes by


which products are developed.
 QA is a managerial tool
 QA aims to prevent defects with a focus on the process used to
make the product. It is a proactive quality process.
 The goal of QA is to improve development and test processes so
that defects do not arise when the product is being developed.
RESPONSIBILITIES OF QA
 The QA department is responsible for ensuring that the quality policies
adopted by a company are followed.
 It helps to identify and prepare the necessary SOPs relative to the control of
quality.
 It must determine that the product meets all the applicable specifications
according to the internal standards of GMP.
 QA also holds responsible for quality monitoring or audit function.
 QA functions to assess operations continually and to advise and guide them
towards full compliance with all applicable internal and external regulations.
RESPONSIBILITIES OF QA

■ Communication with research /development and new product


introduction
■ Batch review and batch release
■ manufactured according to the internal standards of GMP.
■ Customer feedback and satisfaction
■ Vendor assurance and supplier auditing
OBJECTIVES OF QA
■ To achieve an effective QA through continuous self improvement and
outcome assessment of performance.
■ To satisfy the customers with the services provided by the company.
■ To ensure compliance with relevant statutory and safety requirements.
■ To assure the management that the activities are being performed as
designed in all the areas of operations within the organization.
■ To achieve and maintain a level of quality that maximizes industry’s
reputation with the customers.
■ To provide confidence to the customers about quality of company’s
goods and services.
■ To ensure that the policies adopted by the company are being followed.
■ To ensure that each and every product reaching patient is safe,
effective and of standard quality.
RESPONSIBILITIES
ROLE OF QA IN PHARMA INDUSTRY

 To establish quality audit


 To establish procedures and specifications
 To establish manufacturing controls
 To perform laboratory tests
 To review and approve or reject
 To ensure investigation of nonconformance
 To keep management informed
 To describe responsibilities in writing
QA activity flow chart for finished product inspection
Major keywords of Quality assurance

Calibration

Validation

Qualificatio

n
Calibration

■ Calibration determines if a device or instrument is


producing accurate results within the specified limits.
Qualification
 Qualification is part of validation
Qualification is defined as action of proving and documenting
that equipment or ancillary systems are properly installed, work
correctly, and actually lead to the expected results.
Validation
Validation is a process of establishing documentary
evidence demonstrating that a procedure, process, or
activity carried out in production or testing maintains the
desired level of compliance at all stages.
The field of validation is divided into a number of subsections
including the following:
 Equipment validation
 Facilities validation
 HVAC system validation
 Cleaning validation
 Process Validation
 Analytical method validation
 Computer system validation
 Packaging validation etc..
QUALITY CONTROL

 ISO 9000 defines quality control as "A part of quality


management focused on fulfilling quality requirements".
 QC is the part of GMP concerned with sampling, specifications
and testing, documentation and release procedures which
ensure that the necessary and relevant tests are actually carried
out and the materials are neither released for use, nor products
are used for sale & supply until their quality has been
satisfactory.
RESPONSIBILITIES OF QC
 QC is responsible for the day-to-day control of quality within the company.
 This department is responsible for analytical testing of incoming raw materials
and inspection of packaging components, including labelling.
 They conduct in-process testing when required.
 They also conduct the required tests on finished dosage form.
 QC plays a major role in the selection of qualified vendors from whom raw
materials are purchased.
 The environmental areas for manufacturing of various dosage forms are tested
and inspected by QC department.
RESPONSIBILITIES OF QC
 Raw materials control
• Check standards
• Tested according to written procedures
• Rejected materials discarded and accepted material either stored or sent
for further processing.
• Selection of vendors for raw materials
 In-process quality control
• Determine quality of the product at various stages of its manufacture.
• Help to detect any variations in the product
• Monitors over-all features of the product which may affect its quality.
 Monitoring of environmental conditions
• Inspecting the environmental conditions in which both sterile and non-
sterile products would be manufactured and stored.
 Control of packaging components
• Testing packaging materials especially containers and closures.
• Inspect labellings of the final product.
 Finished products control
It ensures that,
• Product contain same amount of drug as present on the label.
• Entire drug present in the formulation
• Drug is stable in the formulation through out its shelf life
• Dosage forms are devoid of any contaminant.
 Documentation (record keeping)
 Stability studies
RESPONSIBILITIES
The Benefits of Quality Assurance and Quality Control

• It gives you a high quality output.


• It increases the efficiency of operations.
• It brings customer satisfaction, which affects your brand and
helps you grow your business.
• If your product is of good quality, you will not need much rework
and there will not be much after-sale support required. This will
help you save a lot of money.
• A high level of confidence and a motivated team.
DIFFERENCE BETWEEN QA AND QC
 QA  QC
 Ensure quality in the processesby  Ensuring quality in products, focused
which products are developed on identifying defects
 Proactive quality process which aims  Reactive process to identify defects
to prevent defects in the process
 To improve development and test  To identify defects in a developed
processes to reduce defects product before it’s released
 Establishes good quality  QC finds and eliminates sources of
quality problems through tools and
equipment.
 Prevention of quality problems  The activities or techniques used to
through planned and systematic achieve and maintain the product
activities including documentation quality, process and services
 Everyone on the team involved in  Quality control is usually the
developing the product is responsible responsibility of a specific team that
for quality assurance tests the product for defects.
 QA is a managerial tool  QC is a corrective tool

 QA is process oriented  QC is product oriented

 EX: Verification  EX: validation/software testing

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