GMP AND VALIDATION

1. CGMP: A detailed study of GMP as prescribed in schedule M of Drugs and Cosmetic act and Rules. Requirements regarding premises, sanitations, personnel, equipment and buiding, documentation and records and processes.
2. Control of production procedures: Manufacturing control - In - Process quality Control for solids, liquids, semisolids and parental products - packaging control.
3. Control of Finished Products: Tablets, Capsules, Parentals, Semi solids and Liquid orals.
4. Validations: Types and protocols of validation - A study of process Validation. Validation of Equipments, Cleaning, Analytical Method Validation-Procedures and examples.
5. Quality control and Quality assurance: Principles and general concepts-Duties and responsibilities of Quality control and Quality assurance departments in a modern pharmaceutical concern - Sources of Quality Variation - Control of quality variation. Raw material control - Quality assurance before start-up and at start-up; Manufacturing control - Packaging materials and Labels control.
6. Concept of statistical quality control - Quality control charts - sampling and sampling plans.

Books:
1. The Theory and practice of Industrial Pharmacy by Leon Lachman. H.A. Libermen and Joseph L. Kanig, 3rd edition.
2. Tablets - Vol. I, II and III by Leon Lachman et al.
3. Modern Pharmaceuticals by Banker.
4. Quality assurance of pharmaceuticals Vol.I and Vol. II published by pharma books syndicate.

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