Tropical Journal of Pharmaceutical Research
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An Overview of Pharmaceutical Validation and Process Controls in Drug Development

Elsie Jatto1 and Augustine O Okhamafe2

Department of Pharmaceutics & Pharmaceutical Technology,  Faculty of Pharmacy, University of Benin, PMB 1154, Benin City, 300001, Nigeria

Tropical Journal of Pharmaceutical Research 2002; 1(2): 115-22

Abstract  Full Text

It has always been known that the 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 and the various approaches and steps involved as well other pertinent consideration.

Keywords: Drug production, pharmaceutical validation, pharmaceutical process control. 

1Present address:  Pharmacy Department, National Hospital, Abuja, Nigeria; 2To whom correspondence should be addressed:  E-mail:  

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Last updated: January 09, 2003