Elsie . Jatto1,
Augustine O Okhamafe2 
For correspondence:- Augustine Okhamafe Email: okhamafe@uniben.edu
Published: 23 December 2002
Citation: Jatto E., Okhamafe AO. An Overview of Pharmaceutical Validation and Process Controls in Drug Development. Trop J Pharm Res 2002; 1(2):115-122 doi: 10.4314/tjpr.v1i2.9
© 2002 The authors.
This is an Open Access article that uses a funding model which does not charge readers or their institutions for access and distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0) and the Budapest Open Access Initiative (http://www.budapestopenaccessinitiative.org/read), which permit unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited..
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.
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