Pharmacy, Quality Assurance, Sem- VI, B pharm

1. QUALITY ASSURANCE AND
QUALITY MANAGEMENT
CONCEPTS
- PRATIK TERSE
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2. QUALITY
 Dictionary: Quality is the standard of something when it is
compared to other things.
 ISO: The totality of features and characteristics of a product or
service that bear on its ability to meet a stated or implied need
Quality
Manufacturer perspective
Quality is to confirm to the specifications.
Consumer perspective
Quality characteristics with price
considerations.
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3. QUALITY ASSURANCE
• Quality Assurance is a management method
• That is defined as all the planned and systematic
actions needed to provide adequate confidence that a
product, service or result will satisfy given requirements
for quality and be fit for use.
• WHO defines QA as the totality of arrangements made
with the object of ensuring that pharmaceutical products
are of the quality required for their intended use.
Quality Assurance:
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4. QUALITY ASSURANCE
Components of Quality Assurance:
1. Strategic or
Organizational level:
This level deals with the
quality policy, objectives
and management.
2. Tactical or Functional
level:
This deals with general
practices such as training,
facilities, operation of QA
3. Operational level:
This deals with the
standard operating
procedures, worksheets &
other aspects of day to day
operations.
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5. QUALITY ASSURANCE
Objectives
of Quality
Assurance:
• Product design and development is
accordance with requirements of cGMP,
GLP, GCP.
• All operations in production are specified
in clear writing.
• Managerial responsibility is specified in
each job description.
• Correct raw material and packaging
material are used.
• Appropriate controls
• Finished products are appropriately
checked
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6. GOOD MANUFACTURING PRACTICES
(GMP)
 Now a days GMP is also known as cGMP (Current Good Manufacturing
Practices)
 As per WHO, GMP is that party of quality assurance which ensures that
products are consistently produced & controlled to the quality standards
appropriate to their intended use & as required by the marketing
authorization.
 Primary aim of GMP is to reduce mix-ups and cross-contamination.
 GMP guidelines are prescribed by every country's drug regulatory authority
& WHO.
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7. GOOD MANUFACTURING PRACTICES
(GMP)
• Clearly defined and systematically reviewed
manufacturing processes.
• Critical steps of production processes are validated
• Appropriate resources: personnel, buildings,
equipment's & materials are available to produce a
quality product
• Manufacturing is based on clearly written procedures
• Operators are trained
Basic requirements for GMP:
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8. QUALITY CONTROL
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QUALITY
CONTROL
As per ISO 9000 Quality control is defined as a part of
quality management focused on fulfilling quality
requirements.
WHO defines QC as, the sum of all procedures undertaken
to ensure the identity & purity of particular pharmaceutical.
Each manufacturing company should have a separate
quality control department.
The QC department must have adequate resources such as
adequate laboratory facilities, chemicals, glassware's, etc.

9. QUALITY CONTROL
Objectives of Quality Control:
• Day to day control maintained over the quality aspects of drug
products.
• Incoming raw materials, in-process goods & finished products
are all tested for compliance with predetermined quality
specifications.
• Environmental monitoring is performed to make sure products
are manufactured, packed & stored under prescribed conditions.
• Instruments are calibrated and working as expected.
• Analytical methods are developed and validated.
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10. QA and QC
 Difference between QA and QC:
Attribute QA QC
Goal Preventing defects Identifying defects
Focus Building quality into
product from design
stage itself
Testing if quality exists in
product after its
manufacturing
Work flow Establish quality
management system,
continuous monitoring of
process
Find source of problem
in quality
Type of tool Managerial Corrective
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11. REGULATORY BODIES
Global Regulatory Bodies:
Country Regulatory Bodies
India Central Drugs Standard Control Organization (CDSCO)
Japan Ministry of Health Labour and Welfare
Australia Therapeutic Goods Administration (TGA)
UK Medicines and Healthcare products Regulatory Agency
(MHRA)
South Africa Medicines Control Council (MCC)
USA Food and Drug Administration (FDA)
China State Food and Drug Administration
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