IJIMT 2014 Vol.5(3): 193-197 ISSN: 2010-0248
DOI: 10.7763/IJIMT.2014.V5.512

Validation Effects and Issues from the Perspective of the Pharmaceutical Industry

Vothia Surian Subramaniam and Shahrul Kamaruddin
Abstract— Quality is an imperative for customers whenever they consider a product or service. It is also important as it relates to life-saving products such as pharmaceuticals. In this regard, the Food and Drug Administration introduced good manufacturing practice (GMP) to maintain and improve the quality of pharmaceutical products. GMP ensures that products are consistently produced and controlled according to the quality standards appropriate to the intended use and as required by the marketing authorization. One of the major GMP requirements is that all of the critical manufacturing equipment, utilities, and facilities in the pharmaceutical industries must be properly validated prior to production. Currently, this practice forms the core of the regulations that are strictly followed by pharmaceutical companies worldwide. This study aims to identify and classify the issues and needs that must be resolved towards a better understanding of the validation process practiced in the pharmaceutical industry.

Index Terms— Good manufacturing practice, pharmaceuticals, validation.

Vothia Surian Subramaniam and Shahrul Kamaruddin are with the School of Mechanical Engineering, Universiti Sains Malaysia, Engineering Campus, 14300 Nibong Tebal, Pulau Pinang, Malaysia (e-mail: sooria999@yahoo.com.my, meshah@usm.my).

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Cite: Vothia Surian Subramaniam and Shahrul Kamaruddin, " Validation Effects and Issues from the Perspective of the Pharmaceutical Industry," International Journal of Innovation, Management and Technology vol. 5, no. 3, pp. 193-197, 2014.

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