Pharmaceutical Master Validation Plan The Ultimate Guide to FDA, GMP and GLP Compliance

The regulatory guidelines such as those of the FDA, Current Good Manufacturing Practices (cGMP) for Pharmaceuticals, and Good Laboratory Practices (GLP) require comprehensively documented systems. The guide-lines mentioned above provide only a set of rules to be followed and leave the speciﬁcity of the working documents to the individual companies.

The purpose of this book is to provide a generic format for a Master Validation Plan, also often called a Validation Master Plan (VMP), using a pharmaceutical manufacturing site with both sterile and non-sterile operations as the case facility. The intent is to show basic format and samples of contents for all the sections of the plan, because it provides a road map for validation to establish FDA requirements master validation pro-cedures, validation programmes, execution protocols, and resources plan-ning and scheduling.

The pharmaceutical, medical device, and biotech industries are regulated worldwide to be in compliance with cGMP and GLP principles. Each company is required to create a VMP to qualify its equipment, utilities, buildings, and personnel. The template VMP available enables the end users to understand the principles and elements of a VMP and provides documentation language that is generic to very speciﬁc depending on the depth of the requirements.

Compliance with FDA regulations by the health care industry over the past decade has been a major goal, especially for those companies intending to export their product to the U.S. market. As a result, the FDA inspects nearly 300 companies throughout the world every year for cGMP and GLP compliance, but only ﬁve or six are able to seek approval for exportation. One reason for this is the absence or inadequacy of a VMP. The key beneﬁts of a VMP include, but are not limited to:

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