Tag: particle counters
Viable and Non Viable Particle Counts
Environmental and Process Monitoring- Annex 1, Section 9.4 In Part 3 of our 5 part blog series, we look at Viable Non Viable (V/NV ) Particle counts regarding Environmental and Process Monitoring as found in Annex 1, Section 9.4: RA should be done to develop a comprehensive environmental monitoring program…
Contamination Control Strategy and Annex 1
Science vs standardization: justification vs blindly following rules. The new auditorsā expectations for a cleanroom monitoring plan Annex 1 requires designing an effective contamination control strategy (CCS) based on a scientific assessment to understand the process and to apply risk management principles. The latest Annex 1 draft frequently uses the…
Quality Risk Management in Annex 1; 6.1
The use of Quality Risk Management (QRM) principles and risk-based approaches are prominent expectations throughout the Annex 1 draft. Risk-based approaches are mentioned 43 times in the draft reinforcing the importance of using Risk Based approaches in all aspects of sterile product manufacturing. In part 2 of our five-part series,…