|Tropical Journal of Pharmaceutical Research|
|Official Journal of Pharmacotherpy Group|
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An Overview of Pharmaceutical Validation and
Process Controls in Drug Development
Jatto1 and Augustine O Okhamafe2
Journal of Pharmaceutical Research 2002; 1(2): 115-22
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.
Drug production, pharmaceutical validation, pharmaceutical process control.
Department, National Hospital, Abuja, Nigeria;
whom correspondence should be addressed: E-mail:
|@2002. TJPR Faculty of Pharmacy, University of Benin, Benin City, Nigeria|
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|Last updated: January 09, 2003|