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Objectives:-
The course is directed towards science graduates contemplating a career in Pharmaceutical Analysis and/or Quality Assurance, or currently employed in the pharmaceutical industry, a research institute, the health service, or a regulatory authority. A broad knowledge of the pharmaceutical sciences is presented with an emphasis placed on both the academic and professional aspects of the subject. The course also prepares graduates for entry into research degree programs in the pharmaceutical sciences. The course is designed to give the students updated knowledge concerning microbiological quality control of different sources of contamination, monitoring of the manufacturing processing, validation of the sterilization processes, and sterility tests
Contents:
Theoretical
Quality management and quality control activities, Good laboratory practicing (GLP) compliance, Quality Assurance and Regulatory Matters, Principals of Analytical Techniques and the use of official monographs. The content of the course is designed to familiarize undergraduates with the QC, GLP and related regulatory protocols; the ability to design analytical procedures and validate them in order to understand, compile, defend and interpret Analytical Profiles and Monographs; the ability to conduct a full examination of a named material to confirm identity and compliance with a pharmacopoeia monograph; The ability to critically review the scientific literature to prepare and present reports on experimental data. The practical module is designed to familiarize undergraduates with all QC/QA/RA activities. Microbiological quality control of different sources of contamination, microbiological monitoring of the manufacture processing, validation and monitoring of the sterile production area, validation of the sterilization processes and routine monitoring , Ed., suitable indicators, sterility tests and evaluation of the applied methods, and evaluation of the preservative efficiency in the pharmaceutical preparations.
Practical
Experimental applications on quality management and quality control activities. Analytical Techniques and the use of official monographs. Sterility tests and evaluation of the applied methods, and evaluation of the preservative efficiency in the pharmaceutical preparations.
Principal Text:
· Quality Assurance Compliance, procedures for Pharmaceutical and Biotechnology Manufactures, Ira C. Peine, 1994.
· Pharmaceutical Microbiology, Hugo and Russel. Blackwell Scientific publication 1998.
Supplementary Text:
· Pharmaceutical Quality Control Lab Manual and CD, GMP (Good Manufacturing Practices) Training for Pharmaceutical Manufacturing, Covering FDA Regulations of Laboratory Results, SOPs (Standard Operating Procedures), and OOS (Out of Standard) and OOT (Out of Trend).
· Results by Daniel Farb, Anthony Luttrell, Robert Kirsch Publisher: University Of HealthCare; (October 2003)
· Handbook of Microbiological and Medical Quality Control. 2000. Stephen Denyer, Norman A.Hodges, Stephen P.Denyer, Rosamand Baird.Routledge.
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