JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Course Objectives

This course deals with the various aspects of quality control and quality assurance

aspects of pharmaceutical industries. It covers the important aspects like cGMP, QC tests, documentation, quality certifications, GLP and regulatory affairs.

Course Outcome

The study of this subject builds the confidence in the minds on the students to

develop and formulate high quality pharmaceutical products.

UNIT - I

• a. Impurity and stability studies: Definition, classification of impurities in drug Substance or Active Pharmaceutical Ingredients and quantification of impurities as per ICH guidelines.
• b. Impurities in new drug products: Rationale for the reporting and control of degradation products, reporting degradation products content of batches, listing of degradation products in specifications, qualification of degradation products
• c. Impurities in residual solvents: General principles, classification of residual solvents, Analytical procedures, limits of residual solvents, reporting levels of residual solvents.

UNIT - II

• a. Concepts of Quality Assurance, Total Quality Management, Philosophy of GMP and cGMP
• b. Guidelines for Quality Assurance of Human Blood Products and large volume parenterals.

UNIT - III

• a. Organization and personnel, responsibilities, training hygiene
• b. Premises: Location, design, plan Layout, construction, maintenance and sanitations, environmental control, sterile areas, control of contamination.
• c. Equipments: Selection, purchase specifications, maintenance, clean in place, sterilize in place – Raw – materials: Purchase specifications, maintenance of stores, selection of vendors, controls and raw materials.

UNIT - IV

• a. Packaging and labeling controls, line clearance and other packaging materials.
• b. Quality Control Laboratory: Responsibilities, good laboratory practices, routine controls, instruments, protocols, non-clinical testing, controls on animal house, data generation and storage.

UNIT - V

Manufacture and controls on dosage forms

• a. Manufacturing documents, Master Formula, Batch Formula, Records, Standard Operating Procedures,
• b. In process quality control on various dosage forms sterile and biological products, standard operating procedures for various operations like cleaning, filling, drying, compression, coating, disinfection, sterilization, membrane filtration etc.

TEXT BOOKS:

• 1. The International Pharmacopoeia Vol 1,2,3,4, 3rd edition General Methods of Analysis Quality Specifications for Pharmaceutical Substances, Excipients, Dosage Forms.
• 2. Quality Assurance of Pharmaceuticals. A Compendium of Guidelines and Related Material Vol. 1 and Vol. 2, WHO 2007)
• 3. GMP by Mehra
• 4. Pharmaceutical Process Validation by Berry and Nash
• 5. How to Practice GMP’s – P.P. Sharma

REFERENCES BOOKS:

• 1. Basic Tests for Pharmaceutical Substances -WHO (1991)
• 2. The Drugs and Cosmetic Act 1940 by Vijay Malik
• 3. Q.A. Manual by D.H. Shah
• 4. SOP Guidelines by D.H. Shah
• 5. Quality Assurance Guide by OPPI
• 6. Good Manufacturing-Practices for Pharmaceuticals, by Graham Bunn and Joseph 6th Ed. D. Nally (Dec 26, 2006)
• 7. Analytical Profiles of drug substances and Excipients – Harry G Brittan, Volume 21 – 30, Elsevier, 2005. M.Pharm I Year II Sem (PHARMACOGNOSY)