Course Synopsis:

This course gives complete overview about the production facility from start of the project up to the production process and how to carry out all project steps according to the guidelines of the GMP. Topics include the background to GMP and cGMP regulations and guidelines and their relevance in the laboratory, process development and pilot plant. 

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Course Outcomes:
Ability to analyze the concepts and the requirements of GMP and Validation, the Standard Operation Procedure (SOP) and Safety and Health Environment (SHE) aspects.
Ability to develop the GMP requirement and primary and secondary bioprocess engineering products, together with the Hazard Analysis and Critical Control Point (HACCP).
Ability to evaluate the utilities and services, laboratory design, process development facilities and pilot manufacturing facilities.

References:

Nally, J.D. 2007. Good Manufacturing Practices for Pharmaceuticals, Sixth Edition, Informa Healthcare Inc, New York, USA.
Alli, I., Food, Quality Assurance, CRC PRESS, New York, 2004.
Bliesner, D.M. 2006. Establishing A Cgmp Laboratory Audit System: A Practical Guide, John Wiley & Sons, Inc., Hoboken, New Jersey.
Bennet, B.  2003. Pharmaceutical Production: an Engineering Guide, Institution of Chemical Engineers (IChemE), Warwickshire, UK.
WHO Guidelines, Quality assurance of pharmaceuticals, Good manufacturing practicesand inspection, WHO Press, World Health Organization, Geneva, Switzerland, 2007.