GMP Compliance Basics
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by: Carly Chaffer
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Word Count: 415
Date: Wed, 8 Sep 2010 Time: 6:01 AM
GMP compliance or Good Manufacturing Practice ensures that safety is a priority throughout the pharmaceutical, medical device, nutraceutical and food industries.
GMP compliance consists of many guidelines which are designed to make sure that medical products for patients and consumers are produced to the very highest of standards and specifications and the basic principles of these are absolutely imperative for the industry to follow and maintain.
A good starting principle for GMP compliance is for companies to make sure that they have defined their manufacturing processes clearly and that controls are in place to regulate those processes. Consistent production is one way in which to ensure that products are manufactured in a GMP compliant way. Of course, part of the process of defining manufacturing processes would be to include a procedure for change management, recording and monitoring any impact that change has on quality standards and then ensuring validation.
Good Manufacturing Practice also stipulates that in order to satisfy GMP compliance, all instructions and procedural practices are recorded using unambiguous language and are written in such a way as to provide absolute clarity, rather than absolute confusion. This is perhaps one of the hardest aspects to GMP compliance when one considers the technical information and demanding processes used to produce some of the pharmaceutical industry's most complex products.
GMP compliance also demands that the industry, like many others, keeps a full and detailed history of the manufacturing process. This includes what is produced and when, how the products that were manufactured have been distributed, where they have been distributed to and for what purpose. This part of GMP compliance enables regulatory authorities to investigate when things go wrong using a proper trail of historical actions and clues and it helps businesses within the industry find problems and errors in their processes quickly and efficiently so that they can be rectified as a priority. Making sure that this process is adhered to is good practice and will enable companies to stay at the top of their game by beign able to improve things as they turn up. Businesses that do use GMP compliance in the best way possible could get a competitive advantage when used and implemented properly.
GMP compliance is important in many ways, but in the end, its instigation and use across the globe is to ensure that patients and consumers have a high level of protection and safety from the products that are produced by pharmaceutical businesses, medical device companies and nutraceutical organisations.
About the Author
Paul recommends the experienced and specialist International pharmaceutical consultants DBA Global who consult and advise on GMP compliance.
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