Story of the Sterite...
Story of the Sterite...
9th February 2021 Podcast: Paul Carton
GMP Annex 1: Changes in Microbial Monitoring - a rapidmicrobiology podcast
This podcast is sponsored by Merck KGaA, Darmstadt, Germany
GMP Annex 1: Changes in Microbial Monitoring - a rapidmicrobiology podcast
In this episode, Anne Klees and Adele Gisselmann (Global Product Managers with Merck KGaA, Darmstadt, Germany) unravel the New GMP Annex I (Draft 2020) and explain what effect its changes and new sections will have on environmental microbial monitoring.
Timestamps:
[1:20] - Key Changes in Annex I
[2:31] - Rapid and Alternative Methods in Annex I
[6:10] - Qualification of Recovery Rates for Air Samplers & Culture Media
[7:45] - Validating Media for its Neutralization Efficiency
[9:05] - Validating Air Samplers
[14:40] - New Sections in Annex I (Aseptic Process Simulation/Media-fill etc.)
[20:28] - How Merck KGaA, Darmstadt, Germany can help with Regulatory Requirements
Speakers:
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If you would like to discuss your Environmental Monitoring requirements with Adele and Anne, please use the 'Request Information' button provided below.
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Date Published: 9th February 2021
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Story of the Steritest™
Story of the Steritest™