Laboratory Requirements
On request of Orkut colleagues with focus on Microbiology laboratory design.
The general requirements of Quality Control Laboratories are explained in Indian schedule M (to download, click here ). Some design aspects of Quality Control Laboratory in Pharmaceuticals is explained in chapter 9 'Laboratory design' of Pharmaceutical Production by Bill Benett. To access chapter 9, click here.
The EU guidelines, chapter 6 gives the GMP expectations from Quality Control function and this does not state any requirement for the laboratory design, men-material interface, managing hot zones, solvent, hazardous areas or instrumentation areas.
In general the Microbiology laboratory design requires cleanroom classification corresponding to the products requirements, microbiological analysis and volume of work. Nevertheless, the best layout, design and contemporary GLP requirements of an Analytical Laboratory of Pharmaceutical company are given by ISPE baseline guide. This also includes the Microbiology Laboratory requirements. To dowload this guideline, click here. Offcourse this is draft document circulated by ISPE for comments and also copyright protected.
Dr. Sutton Scott also explains in detail USP <1117> requirements, but this is more on Microbiology laboratory practices. Click here to get a peep into his work.
Dipankar Kaul, June 04, 2009