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Vol 1, No 2 (2002)
by 1st of February, 2002

An Overview of Pharmaceutical Validation and Process Controls in Drug Development.


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Abstract in English

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

Language
English
Type
Articles
Firstpage Number
115-122
Date of issue
Volume
1
Issue
2
Category
Cite
MIA

E Jatto, et al. "An Overview of Pharmaceutical Validation and Process Controls in Drug Development." Tropical Journal of Pharmaceutical Research 1.2 (2002): 115-122.


Harvard

E Jatto, AO Okhamafe, 2002. An Overview of Pharmaceutical Validation and Process Controls in Drug Development.. Tropical Journal of Pharmaceutical Research, 1(2), pp.115-122.


Chicago

E Jatto, AO Okhamafe. "An Overview of Pharmaceutical Validation and Process Controls in Drug Development.." Tropical Journal of Pharmaceutical Research 1, no. 2 (2002): 115-122.


ДСТУ 2006

E Jatto, AO Okhamafe. An Overview of Pharmaceutical Validation and Process Controls in Drug Development. / E Jatto, AO Okhamafe // Tropical Journal of Pharmaceutical Research. - 2002. Vol. 1. - № 2. - pp. 115-122.


ГОСТ 2008

E Jatto, AO Okhamafe. An Overview of Pharmaceutical Validation and Process Controls in Drug Development. // Tropical Journal of Pharmaceutical Research. 2002. № 2 (1). С. 115-122.


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