GMP Annex 1: Changes in Microbial Monitoring

WEBINAR

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