Basic Architectural Design Considerations for a Laboratory

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The Ministry of Health & Family Welfare, under the Drugs & Cosmetics Act, has laid down “Good Laboratory Practices” requirements and made the compliance of GLP mandatory from 1st November 2010, for all pharma companies. Close to the requirement of Indian Law; WHO has also come out with a draft guidance document of GLP for all establishments engaged in testing of pharmaceutical products. Further for last few years it is also noticed that laboratory’s functioning, its design, layout, aesthetic appearance and adequacy of work area have been one of the major areas where various
regulatory officials have been spending time and making observations for compliance. Shortcomings in design, layout, aesthetic appearance and adequacy of work area found its mention in inspection report either because of improper understanding and far-sight (by project persons, technical persons or management personnel) of these aspects while setting up laboratories or poor execution work for time constrain / money constrain. The above two publications has raised a furor in the industry to retrofit the existing facilities as well those upcoming ones are now focusing on to make their upcoming set-up’s GLP/GMP compliant.

 

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