GMP Annex 1: Changes in Microbial Monitoring
Episode 3, Jan 15, 2021, 10:29 AM
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:
Dr Anne-Grit Klees, is a Global Product Manager for Environmental Monitoring at Merck KGaA, Darmstadt, Germany. She is a microbiologist and graduated at Philipps Universität Marburg in 1992. Since then she has been Global Product Manager for Biotest, heipha Dr Müller GmbH and Merck Life Science with strong expertise on environmental monitoring in pharmaceutical industries including ready-to-use culture media for air, surface and personnel monitoring.
Adèle Gisselmann is Global Product Manager for Environmental Monitoring at Merck KGaA, Darmstadt, Germany. She has three years of experience in technical support for process solutions at Merck KGaA, Darmstadt, Germany, and a background in the food and beverage industries and microbiology.
[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:
Dr Anne-Grit Klees, is a Global Product Manager for Environmental Monitoring at Merck KGaA, Darmstadt, Germany. She is a microbiologist and graduated at Philipps Universität Marburg in 1992. Since then she has been Global Product Manager for Biotest, heipha Dr Müller GmbH and Merck Life Science with strong expertise on environmental monitoring in pharmaceutical industries including ready-to-use culture media for air, surface and personnel monitoring.
Adèle Gisselmann is Global Product Manager for Environmental Monitoring at Merck KGaA, Darmstadt, Germany. She has three years of experience in technical support for process solutions at Merck KGaA, Darmstadt, Germany, and a background in the food and beverage industries and microbiology.