Quality Assurance in Pharmaceutical Industry

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QUALITY ASSURANCE IN

PHARMACEUTICAL INDUSTRY

Quality Assurance in Pharmaceutical Industry


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Q C

Offices Gowning

Canteen

Incoming goods

Corridor

Corridor

Shipping

Corridor

Packaging

Weighing Processing

Filling

Raw Materials

& Packaging Storage

Washing

Machine

Shop

Finished Products Storage

Corridor Utilities and Services Waste Treatment

Red: Man Green: Material

General Materials and People Flow in Pharmaceutical Industry


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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


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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 chartDispensing

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

Incorrect Ingredient16%

Incorrect Amount17%

No Active Ingredient60%

Correct Ingredient7%


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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

Documents

Quality Assurance in Pharmaceutical Industry