QUALITY ASSURANCE

IN
PHARMACEUTICAL INDUSTRY

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General Materials and People Flow in Pharmaceutical Industry

QC Offices Canteen
Gowning
Incoming
goods Shipping
Corridor
Corridor
Corridor
Raw
Red: Man
Materials
Packaging Finished
& Filling Products
Packaging Weighing Processing
Storage
Storage

Washing Machine
Shop Green: Material
Corridor
Utilities and Services Waste Treatment
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• QUALITY
• The totality of features and characteristics of a
medicinal product and its ability to satisfy stated and/or
implied needs

• QUALITY ASSURANCE
• The sum total of the organized arrangements made
with the object of ensuring that drug products are of
the quality required for their intended use.

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GOOD MANUFACTURING PRACTICE (GMP) Tool of QA

Meaning of GMP- G satisfactory/appropriate

M- Making on a large scale.
P – way of doing something
• How GMP required.
• Object : Quality can not be tested into a batch of product but must be built
into each batch of product during all stages of the manufacturing process.
• Motto –To prepare a product which is safe, pure, effective.
• Values – Safety/ Identity/ strength/ purity/ quality
• Key elements of GMP – Qualified & trained personnel / adequate premises
and space / suitable equipments / correct materials / approved procedures
and instructions / suitable storage and transport.
No pain ……………………..No gain
• Evaluate what is wrong rather then who is wrong
• Know not only, what should be done , but also what should not be done
too.

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 Why QA is required
• It is a regulatory requirement
• Various qualification activities
• It ensure the appropriateness of product lifecycle
• Ensure the product Quality at various stages of product.
• Provide various QMS Tools
• Post marketing surveillance
• Ensure appropriate infrastructure encompassing
organizational structure, procedures, processes, and
resources for drug product manufacturing
• Ensure systematic actions necessary to provide adequate
confidence that product will meet quality standards and
expectations Quality Assurance in Pharmaceutical
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Quality relationships
Quality Management

Quality Assurance

GMP

DRUG PRODUCT
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Quality Assurance: Essential At All Stages

Quality Assurance Cycle

Research
Development
Raw Materials
Facilities
Documentation
Equipment
Personnel

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Elements of the Quality Assurance Cycle in
Pharmaceutical Manufacturing
• Research
• Development
• Documentation
• Raw Materials
• Facilities
• Equipment
• Personnel and Supervision
• Monitoring, Feedback, Follow-up

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 Key Elements of GMP
Personnel
(Training, Hygiene)

Documentation Premises
(Equipment)

Materials
(Supplies, Ingredients)

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 General Process flow chart
Dispensing

Sifting & Milling

Granulation/ Mixing / Blending

Compression, Coating, Capsulation, Filling, Inspection

 Packaging

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Manufacturing Process and Procedures
• Dispensing / Weighing
• Mixing / Granulation / Preparation
• Compression / Encapsulation / Filling
• Equipment, Operational & Process
Qualification
• Validation & calibration
• Documentation and record keeping
• Yield Reconciliation

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 Quality Assurance Throughout
the Manufacturing Process
• Monitoring environmental conditions under
which products are manufactured/stored
• Monitoring of air and water systems to
prevent contamination– Air Handling Units
• Monitoring of humidity
• Monitoring of personnel
• Feedback and follow-up

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Major Risks in Pharmaceutical Production

• Contamination of products (microbial,

particulate or other)
• Incorrect labels on containers
• Insufficient active ingredient
• Excess active ingredient
• Poor quality raw materials
• Poor formulation practices
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 Impact of poor quality medicine
• 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
• Does not save anyone any money in the long
term
• Hurt everyone – patients, health care workers,
policy makers, regulators, manufacturers
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Analysis of Substandard Medicines
Correct Ingredient
Incorrect Ingredient
7%
16%

Incorrect Amount
17%

No Active Ingredient
60%

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Role of Quality Assurance
• Ensure appropriate infrastructure encompassing organizational
structure, procedures, processes, and resources for drug product
manufacturing
• Ensure systematic actions necessary to provide adequate confidence
that product will meet quality standards and expectations

Good Manufacturing Practices are

• Pivotal to quality assurance
• Everyone’s responsibility (manufacturers, purchasers, distributors,
consumers)
• Clear, transparent, documented, readily observable
• On-going, consistent, reproducible
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• GMP are aimed at reducing risks inherent in
pharmaceutical production
• Qualification and validation provides
confidence in manufacturers’ processes
• Prequalification provides greatest assurance
regarding quality of pharmaceutical products,
based on GMP and product dossier

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 MUKESH SINGH
MANAGER CQA
RANBAXY LABORATORIES LIMITED

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