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Paper Information

Title: 

MANAGEMENT OF PHARMACEUTICAL RECOMBINANT PRODUCTION TECHNOLOGY

Type: POSTER
Author(s): KAGHAZIAN H.,NOJOUMI S.A.
 
 
 
Name of Seminar: IRANIAN CONGRESS OF PHYSIOLOGY AND PHARMACOLOGY
Type of Seminar:  CONGRESS
Sponsor:  PHYSIOLOGY AND PHARMACOLOGY SOCIETY, MASHHAD UNIVERSITY OF MEDICAL SCIENCE
Date:  2007Volume 18
 
 
Abstract: 

In this article we will discuss the mail regulation that it will be need in recombinant protein production technology such as: Process Management, Raw Material Considerations, Equipment Design Consideration, Containment and Biosafety, Support Requirements and Stistical Techniques.
We will have a discussion about Process Management that consist of people and training, documentation, preventive procedure, process synthesis, process monitoring and process scheduling. Raw Material Considerations is a consideration of critical raw materials, raw material testing, supplier & vendor Audits. Equipment Design Consideration is in this era: sterilizability, maintenance of process, integrity, cleanability and system reliability. Containment and Biosafety, Support Requirements and the organization shall determine the needs regarding statistical techniques in order to establish, control and verify processcapability and product characteristics.Main statistical tools are: Simple graphics, Histograms Cause and effect diagrams, Pareto Diagrams, Dispersion diagrams, Significance tests, Correlation and Regression, Design of experiments, Control Charts and Sampling Inspection.

 
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