QA and QC QA is the sum total of organized arrangements made with the object of ensuring that product will be of the

e Quality required by their intended use. QC is that part of GMP which is concerned with sampling, specifications, testing and with in the organization, documentation,and release procedures which ensure that the necessary and relevant tests are carried out QA- All those planned or systematic actions necessary to provide adequate confidence that a product will satisfy the requirements for quality QC-Operational laboratory techniques and activities used to fulfill the requirement of Quality QA is company based QA is company based

QA Quality assurance is a wide ranging concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. QA is the heart and soul of quality control QA = QC + GMP

Goals of Medicine QA To make certain that each medicine reaching a patient is safe, effective, and of standard quality Obtaining quality products that are safe and effective through structured selection and procurement methods Maintaining quality products through the appropriate storage, distribution, monitoring, and use by prescribers, dispensers, and consumers

Determinants of Medicine Quality Identity: Active ingredient Purity: Not contaminated with potentially harmful substances

Potency: Usually 90110% of the labeled amount Uniformity: Consistency of color, shape, size Bioavailability: Interchangeable products? Stability: Ensuring medicine activity for stated period

How Is Quality Assessed? INSPECTION of products on arrival Visual inspection Product specification review (including expiration dates)

LABORATORY TESTING for compliance with pharmacopoeial standards International Pharmacopoeia European Pharmacopoeia U. S. Pharmacopeia British Pharmacopoeia National Pharmacopoeia

BIOAVAILABILITY DATA

How Is Medicine Quality Assured? Product selection Long shelf-life Acceptable stability Acceptable bioavailability

Selection of appropriate suppliers Supplier pre-qualification Request samples from new suppliers

Request specific reports and data for certain medicines (e.g., bioavailability and stability studies) Collect and maintain information on supplier performance

Product certification GMP certificate of manufacturer Product/batch certification (COA) Random local testing

Contract and procurement specifications Pharmacopeia reference standard Local language for product label Standards for packaging to meet specific storage and transport conditions

Appropriate storage, transport, dispensing, and use procedures Pharmaceutical distribution and inventory control procedures Provision for appropriate storage and transport including adequate temperature control, security, and cleanliness Explicit enforcement of cold chain procedures Appropriate dispensing: containers, labeling, counseling Avoidance of repacking unless quality control in place

Product monitoring system Problem reporting: who, how, where, and to whom; what additional measures; what follow-up information Product recalls: hospital or country level

Assessing quality includes Inspection of medicines Laboratory testing when necessary

Assuring quality includes Selection of medicines, dosage forms, and packaging Use of prequalified suppliers Product certification Preparation and enforcement of quality-related contract specification Appropriate storage, transport, dispensing, and use Product monitoring systems

The system of quality assurance appropriate to the manufacture of pharmaceutical products should ensure that:

Pharmaceutical products are designed & developed in a way that takes account of the requirement of GMP & other associated codes such as GLP & GCP. Production & control operation are clearly specified in a written form & GMP requirement are adopted. Managerial responsibilities are clearly specified in job descriptions Arrangements are made for the manufacture, supply & use of the correct starting & packaging materials All necessary controls on starting materials, intermediate products, & bulk products & other in-process controls, calibration, & validations are carried out The finished products is correctly processed & checked, according to the defined procedures Authorized persons have certified that each production batch has been produced & controlled in accordance with the requirements of the marketing authorization & relevant regulations to the production, control & release of pharmaceutical products Satisfactory arrangements exist to ensure , the pharmaceutical products are stored, distributed, & subsequently handled so that quality is maintained throughout the life.