JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Course Objectives

This course deals with the understanding and process for auditing in

pharmaceutical industries. This subject covers the methodology involved in the auditing process of different in pharmaceutical industries.

Course Outcome

Upon completion of this course the student should be able to

• To understand the importance of auditing
• To understand the methodology of auditing
• To carry out the audit process
• To prepare the auditing report
• To prepare the check list for auditing

UNIT - I

Introduction: Objectives, Management of audit, Responsibilities, Planning process, information gathering, administration, Classifications of deficiencies

UNIT - II

Role of quality systems and audits in pharmaceutical manufacturing environment: cGMP Regulations, Quality assurance functions, Quality systems approach, Management responsibilities, Resource, Manufacturing operations, Evaluation activities, Transitioning to quality system approach, Audit checklist for drug industries.

UNIT - III

Auditing of vendors and production department: Bulk Pharmaceutical Chemicals and packaging material Vendor audit, Warehouse and weighing, Dry Production: Granulation, tableting, coating, capsules, sterile production and packaging.

UNIT - IV

Auditing of Microbiological laboratory: Auditing the manufacturing process, Product and process information, General areas of interest in the building raw materials, Water, Packaging materials.

UNIT - V

Auditing of Quality Assurance and engineering department: Quality Assurance Maintenance, Critical systems: HVAC, Water, Water for Injection systems, ETP.

REFERENCES BOOKS:

• 1. Compliance auditing for Pharmaceutical Manufacturers. Karen Ginsbury and Gil Bismuth, Interpharm/CRC, Boca Raton, London New York, Washington D.C.
• 2. Pharmaceutical Manufacturing Handbook, Regulations and Quality by Shayne Cox Gad. Wiley- Interscience, A John Wiley and sons, Inc., Publications.
• 3. Handbook of microbiological Quality control. Rosamund M. Baird, Norman A. Hodges, Stephen P. Denyar. CRC Press.2000.
• 4. Laboratory auditing for quality and regulatory compliance. Donald C. Singer, Raluca-loana Stefan, Jacobus F. Van Staden. Taylor and Francis (2005). M.Pharm I Year II Sem (Pharmaceutical Quality Assurance)