NewProfessionalArticleInvolvingTheBAVInstituteTheNewAnnex1

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Jan 4, 2024 - Pharmacy

NewProfessionalArticleInvolvingTheBAVInstituteTheNewAnnex1

In the pharmaceutical journal pharmind, the December 2023 issue published the article titled “The New Annex 1 – Implementation in the Non-Sterile Area”.

The authors are Dr. Marcel Goverde from MGP Consulting GmbH and Joelle Nussbaum from the BAV Institute. The article comprehensively explains the requirements of the new Annex 1 with regard to products in the non-sterile pharmaceutical area. Specifically, it addresses:

-          Implementation of Annex 1 in the non-sterile area

-          Cleanroom classification for non-sterile pharmaceuticals

-          Relevant microbiological changes

It is worth noting that microorganisms from cleanroom classes A and B should be identified to the species level. Even in case of exceedances in classes C and D, the found isolates should be identified.

The BAV Institute offers fast and reliable identifications using MALDI-TOF under GMP. Contact us!

The team at BAV Institute is available for all questions regarding quality control and monitoring of non-sterile pharmaceuticals.

Source:

Article, December issue via Link