Science vs standardization: justification vs blindly following rules. The new auditors’ 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 terms “risk” “justify” and “strategy”, […]
How to Achieve Quality by Design (QbD) in a new Pharmaceutical Fill Line: Intro and Regulatory (Series Part 1 of 6)
In this blog series we will examine what a new fill line looks like with and without QbD implemented at the design phase. We will study each critical area of the fill line and the activities necessary to effectively bring the control features into effect. These examples come from real-world applications experienced by the Particle Measuring Systems’ Advisory Services Team. Our team has over 70 years of collective experience working in and advising cleanroom users around the world.
Annex 1 Single Use Systems (SUS) Requirements & the BioCapt Single Use Impactor
The new EU GMP Annex 1 rev 12 states, regarding single use systems: Chapter 8 . Production and Specific Technologies Paragraph : Single use systems (SUS) Annex 1 rev Dec 2017 – (8.117): Single use systems (SUS) are those technologies used in manufacture of sterile medicinal products which are designed to replace reusable equipment. SUS […]
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.
Samsung gives PMS® an «A» rating for Service
At PMS® we understand the importance of reliable instrument service and ongoing relationships. After our instruments are installed, our work isn’t over. High sensitivity instruments need ongoing care. That is why we work hard to provide our customers with the highest level of instrument service and calibration, no matter where they are in the world. […]
Calibration and Spectrum Troubleshooting: Span Calibration (Series Part 3 of 4)
This blog series introduces the AirSentry® II analyzer and built-in diagnostic tools accessed with its Ion Mobility Spectrometry (IMS) software.
Calibration and Spectrum Troubleshooting: IMS Spectrum Introduction, Measurement and Calibration (Series Part 1 of 4)
This blog series introduces the AirSentry® II analyzer and built-in diagnostic tools accessed with its Ion Mobility Spectrometry (IMS) software.
Electronic Data in Pharmaceutical Manufacturing: Real-Time Microbial Monitoring (Series Part 6 of 6)
In this six-part blog series, we examine common issues with data transfer, integrity, analysis, reporting and storage that we encounter as cleanroom owners and users every day. We’ll explore how automation and electronic solutions, within the parameters of Regulatory Authorities and cGMP, can help improve efficiency and product quality.
