JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Course Objectives

The main purpose of the subject is to understand about validation and how it can

be applied to industry and thus to improve the quality of the products. The subject covers the complete information about validation, types, methodology and application.

Course Outcomes

Upon completion of the subject student shall be able to

• Explain the aspect of validation
• Carryout validation of manufacturing processes
• Apply the knowledge of validation to instruments and equipments
• Validate the manufacturing facilities

UNIT - I

Introduction: Definition of Qualification and Validation, Advantage of Validation, Streamlining of Qualification & Validation process and Validation Master Plan. Qualification: User Requirement Specification, Design Qualification, Factory Acceptance Test (FAT)/ Site Acceptance Test (SAT), Installation Qualification, Operational Qualification, Performance Qualification, Re- Qualification (Maintaining status-Calibration Preventive Maintenance, Change management), Qualification of Manufacturing Equipment, Qualification of Analytical Instruments and Laboratory equipments.

UNIT - II

Qualification of analytical instruments: Electronic balance, pH meter, UV-Visible spectrophotometer, FTIR, GC, HPLC, HPTLC Qualification of Glassware: Volumetric flask, pipette, Measuring cylinder, beakers and burette.

UNIT - III

Qualification of laboratory equipments: Hardness tester, Friability test apparatus, tap density tester, Disintegration tester, Dissolution test apparatus. Validation of Utility systems: Pharmaceutical water system & pure steam, HVAC system, Compressed air and nitrogen.

UNIT - IV

Cleaning Validation: Cleaning Validation - Cleaning Method development and Validation, validation of analytical method used in cleaning. Cleaning of Equipment. Cleaning of Facilities. Cleaning in place (CIP).

UNIT - V

Analytical method validation: General principles, Validation of analytical method as per ICH guidelines and USP.

REFERENCES:

• 1. B. T. Loftus & R. A. Nash, "Pharmaceutical Process Validation", Drugs and Pharm Sci. Series, Vol.129, 3rd Ed., Marcel Dekker Inc., N.Y.
• 2. The Theory & Practice of Industrial Pharmacy, 3rd edition, Leon Lachman, Herbert A. Lieberman, Joseph. L. Karig, Varghese Publishing House, Bombay.
• 3. Validation Master plan by Terveeks or Deeks, Davis Harwood International publishing.
• 4. Validation of Aseptic Pharmaceutical Processes, 2nd Edition, by Carleton &Agalloco, (Marcel Dekker).
• 5. Michael Levin, Pharmaceutical Process Scale-Up‖, Drugs and Pharm. Sci.Series, Vol. 157,2nd Ed.,Marcel Dekker Inc., N.Y.
• 6. Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, Syed Imtiaz Haider
• 7. Pharmaceutical Equipment Validation: The Ultimate Qualification Handbook, Phillip A. Cloud, Interpharm Press
• 8. Validation of Pharmaceutical Processes: Sterile Products, Frederick J. Carlton (Ed.) and James Agalloco (Ed.), Marcel Dekker, 2nd Ed.
• 9. Analytical Method validation and Instrument Performance Verification by Churg Chan, Heiman Lam. M.Pharm I Year I Sem (Industrial Pharmacy)