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GMP Compliance in Cleanroom Environments

Current good manufacturing practice (cGMP) regulations are the means by which manufacturers, processors and packagers of drugs, medical devices, food and blood can ensure their products are safe, pure and effective. The objective is to prevent instances of contamination, mix-ups and errors by addressing issues such as record keeping, personnel qualifications and training, hygiene and housekeeping, cleanliness, equipment verification and process validation.

However, by its own admission, an organisation responsible for helping companies comply with GMP acknowledges that the regulations are as beneficial to commerce as they are to the consumer. On its website, the GMP Institute notes: "Compliance and performance are the goals of every food, drug, cosmetic, blood and medical device manufacturer. But they don't just happen. They are achieved when the FDA's GMP regulation becomes a lifestyle shared by everyone in the organisation. Compliance and performance occur only if facilities strive toward a proactive management system."

The ultimate aim of these regulations, which were originally championed by the US Food and Drug Administration (FDA) under the authority of the Federal Food, Drug and Cosmetic Act, is to protect consumers from purchasing products that are ineffective or dangerous. Legislation with identical objectives can be seen in the GMPs published in the EU. To enforce the widespread adoption of both sets of principles, failure to comply with GMP regulations is punishable by product recalls, seizures, fines and even jail sentences.


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By Gordon Farquharson, Chartered Engineer and Principal Consultant, Pharmaceutical division of Bovis Lend Lease

Gordon Farquharson is a Founder Member and past Chairman of the UK Parenteral Society and is active in the ISPE, R3 Nordic Association, PDA, and the UK's SEE. He was Chair of the ISPE European Education Committee and was voted ISPE Member of the Year in 2001.

Chairman of BSI's LBI 30 Committee and of CEN Technical Committee 243, he is working on the ISO TC209 and CEN TC243 family of contamination control standards. Lecturing and teaching extensively, he has written several papers and contributed to recent books on cleanroom and isolator technology.

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Gordon Farquharson
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