Monday, 18 February 2019

E-learning module from Pharmig supports Annex 1 disinfection requirements


In December 2017, the European Medicines Agency issued a new draft of EU GMP Annex 1 for sterile medicinal products manufacture. 1 While the draft has yet to be converted into a finalised document, much of what is contained within the document is being used by European inspectors to assess facilities (this is unsurprising given that the revisions are intended to codify current best practices). Central to the update is the requirement for each facility to develop a contamination control strategy, and central to such a strategy is the cleaning and disinfection of cleanrooms. The application of detergents and disinfectants to well-designed and operated cleanrooms is essential for contamination control.

Tim Sandle has written a new article on e-learning solutions for cleaning and disinfection practices:

Pharmig, the not-for-profit professional organisation representing pharmaceutical microbiologists, has recognised these trends and the associated need to address cleaning and disinfection training and competency standards. Part of Pharmig’s remit is to develop training and education in relation to microbiology. Weighing up different options for delivering training, Pharmig selected an e-learning route and subsequently developed an interactive training package. This article considers the benefits of e-learning, the new on-line module from Pharmig, as well as the key requirements from the revised Annex 1 in relation to disinfection contamination control.

Reference:

Sandle, T. (2018) E-learning module from Pharmig supports Annex 1 disinfection requirements, Clean Air and Containment Review, Issue 36: 20-23

For details contact Tim Sandle


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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