quality assurance in pharmaceutical industry

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QUALITY ASSURANCE IN

PHARMACEUTICAL INDUSTRY

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.

Quality Assurance in Pharmaceutical Industry

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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

Quality Assurance in Pharmaceutical Industry

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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)

Quality Assurance in Pharmaceutical Industry

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Quality Assurance in Pharmaceutical Industry

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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

Quality Assurance in Pharmaceutical Industry

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Quality Assurance in Pharmaceutical Industry

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MUKESH SINGH MANAGER CQA

RANBAXY LABORATORIES LIMITED