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Tropical Journal of Pharmaceutical Research
Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, Nigeria
ISSN: 1596-5996
EISSN: 1596-9827
Vol. 1, No. 2, 2002, pp. 115-122
Bioline Code: pr02016
Full paper language: English
Document type: Research Article
Document available free of charge

Tropical Journal of Pharmaceutical Research, Vol. 1, No. 2, 2002, pp. 115-122

 en Review Article - An Overview of Pharmaceutical Validation and Process Controls in Drug Development
Elsie Jatto and Augustine O. Okhamafe

Abstract

It has always been known that facilities and processes involved in pharmaceutical production impact significantly on the quality of the products. The processes include raw material and equipment inspections as well as in-process controls. Process controls are mandatory in good manufacturing practice (GMP). The purpose is to monitor the on-line and off-line performance of the manufacturing process, and hence, validate it. Thus validation is an integral part of quality assurance.

This overview examines the need for pharmaceutical validation, the various approaches and steps involved, and other pertinent considerations.

Keywords
Drug production, pharmaceutical validation, pharmaceutical process control

 
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Alternative site location: http://www.tjpr.org

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