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Paper Information

Title: 

NEW CHALLENGES IN ENSURING BIOPHARMACEUTICAL QUALITY

Type: SPEECH
Author(s): KHADEM A.R.*
 
 *PRODUCTION AND RESEARCH COMPLEX, PASTEUR INSTITUTE OF IRAN, TEHRAN 13164, IRAN
 
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 the past, quality control of drugs and biologics depend on use of variety of testing methods to ensure that the products were safe and effective. Quality control of biopharmaceutical products has always relied on three components: control of the starting materials; control of the production process and control of the final product. Tests are now able to detect potential hazards with a better sensitivity than before and an increasing array of physicochemical methods allows a much better characterization of the product. In addition to sophisticated tests biopharmaceutical regulations entails a number of other procedures to ensure quality. These include characterization of starting materials by supplier audit, cell banking, seed lot systems, compliance with the principles of Good Manufacturing Practices, enhanced pre and post marketing surveillance and lot release. These procedures help assure biopharmaceutical efficacy, safety and quality.

 
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