Pharmaceutical Validation

Pharmaceutical Validation - E Jatto & AO Okhamafe Tropical...

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E Jatto & AO Okhamafe Trop J Pharm Res, December 2002; 1 (2) 115 Tropical Journal of Pharmaceutical Research, December 2002; 1 (2): 115-122 © Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, Nigeria. All rights reserved . Available online at http://www.tjpr.freehosting.net Review Article An Overview of Pharmaceutical Validation and Process Controls in Drug Development Elsie Jatto 1 and Augustine O. Okhamafe 2 Department of Pharmaceutics & Pharmaceutical Technology, Faculty of Pharmacy, University of Benin, PMB 1154, Benin City, 300001, Nigeria 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. 1 Present address: Pharmacy Department, National Hospital, Abuja, Nigeria 2 To whom correspondence should be addressed: E-mail: [email protected]
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E Jatto & AO Okhamafe Trop J Pharm Res, December 2002; 1 (2) 116 Introduction The development of a drug product is a lengthy process involving drug discovery, laboratory testing, animal studies, clinical trials and regulatory registration. To further enhance the effectiveness and safety of the drug product after approval, many regulatory agencies such as the United States Food and Drug Administration (FDA) also require that the drug product be tested for its identity, strength, quality, purity and stability before it can be released for use. For this reason, pharmaceutical validation and process controls are important in spite of the problems that may be encountered 1 . Process controls include raw materials inspection, in-process controls and targets for final product. The purpose is to monitor the on-line and off-line performance of the manufacturing process and then validate it. Even after the manufacturing process is validated, current good manufacturing practice also requires that a well-written procedure for process controls is established to monitor its performance 2 . This paper provides an overview of pharmaceutical validation and process controls in drug development. The validation concept can be applied to new drugs, new dosage forms and generic drug development. Essentials of Pharmaceutical Validation
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This note was uploaded on 03/29/2010 for the course CHEM CHEM 200 taught by Professor Bennet during the Spring '09 term at San Diego State.

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Pharmaceutical Validation - E Jatto & AO Okhamafe Tropical...

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