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