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Pharmaceutical Manufacturing and Packing Sourcer

Validation - The Evolution

Validation, according to the FDA Code of Federal Regulations CFR 820.3, means "confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled".

Everyone within or serving the pharmaceutical industry knows about and is affected by the activities and requirements to carry out successful validation, sometimes referred to as Very Arduous Lengthy Involved and Detailed Attempt to Test Everything. It is the single word, which spans a multiplicity of disciplines ranging from the development and clinical trials of a new pharmaceutical preparation to the quality assurance of the equipment on which it is to be manufactured and packed.

Although the requirements of the regulatory authorities are specific, and are subject to guideline documentation, pharmaceutical companies determine the scope and validation strategy for their processes and equipment. Such are the requirements from regulatory bodies, in particular the FDA establishment - with documented evidence that a specific process and associated equipment will produce a finished product consistently meeting all predetermined quality attributes - that the more enlightened equipment manufacturers have concluded that there is a greater role for them to support their customers.


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By George Smith, Head of Process Technology and Validation, at Manesty


George Smith is Head of Process Technology and Validation at Manesty. He has held several key positions within the pharmaceutical and related industries and has several publications in tablet coating and compression.


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George Smith
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