In the final part of our five part series of Quality Risk Management per Annex 1, we explore the benefits of a Cleanroom Process Risk Assessment and how our Contamination Control Advisers can provide you with one. Process Risk Assessment: Why it’s important A process risk assessment helps you to to ensure risks are properly […]
Potential Cleanroom Sampling Points per Annex 1 Draft
In part 4 of our part 5 blog series on Annex 1 Quality Risk Management, we discuss cleanroom sampling points. Definition of potential sampling points Sample points include particle counters and microbial monitors. Identification of critical areas by HACCP analysis and process understanding Choose points within the critical areas according to defined criteria When performed […]
Viable Non Viable Particle Counts
Viable, 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 […]
Quality Risk Management (QRM), Annex 1, Section 2
In Annex 1 Quality Risk Management (QRM) principles and risk-based approaches are prominent expectations. 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. Here we highlight requirements related to Quality Risk Management that are specifically mentioned in Annex 1, including: […]
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, we highlight requirements related […]
Compressed Gas Contamination Monitoring in Pharma and Cosmetics Manufacturing: Monitoring Program (Series Part 2 of 2)
The regulatory requirements and best practices for monitoring compressed gasses in the Pharmaceutical and Cosmetics & Personal Care industries are explored.
Compressed Gas Contamination Monitoring in Pharma and Cosmetics Manufacturing: Standards (Series Part 1 of 2)
The regulatory requirements and best practices for monitoring compressed gasses in the Pharmaceutical and Cosmetics & Personal Care industries are explored.
It is possible for pharmaceutical quality to be the combination of Quality by Design (QbD) and current Good Manufacturing Practices (cGMP)?
During the final discussion of pharmaceutical control strategies, presented by Anna Campanella, the following question was asked: It is possible for pharmaceutical quality to be the combination of Quality by Design (QbD) and current Good Manufacturing Practices (cGMP)? The following is a summary of that noteworthy discussion.
Pinpointing a particle source with the Handilaz® Mini II handheld aerosol particle counter.
Pinpointing particle sources can be a challenge in cleanrooms and laboratory flow equipment where the movement of clean air can mask particle generators such as faulty filters, motors, robots, operators and residual dust.
Calibration and Spectrum Troubleshooting: Troubleshooting Abnormal IMS Spectrums (Series Part 4 of 4)
This blog series introduces the AirSentry® II analyzer and built-in diagnostic tools accessed with its Ion Mobility Spectrometry (IMS) software.
