Thursday, 25 February 2016

Environmental Monitoring Program: Hot topics in Microbiology & Best Practices


The manufacture of sterile pharmaceutical product requires specific care Regarding environment, premises and practice of the personnel. Regulations in place to be used by the Pharmaceutical Industry give requirements on the environmental monitoring program. With the publication of FDA Warning Letters and 483 That form shows environmental monitoring procedure and practice of the staff belong to top 10 of the gaps found During inspections.

Benedict RAMOND has written an interesting article for the magazine La Vague. The article can be found here.

Here is an extract:

“This article, for the Environmental Monitoring program (EM) in aseptic processing as well in Conventional Clean Rooms (CCR) or using Isolator / RABS technology: Describes the main expectations of the r├Ęglements in place, presents the hot topics in microbiology and Gives solutions for implementation of best practices. From the gaps highlight highlighted by FDA During inspections, Microbiology The Following topics will be Described: samples rent justification, missing samples and data interpretation, trending system and CAPA system.”

Posted by Dr. Tim Sandle

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