Imagine a world where giving an getting approvals was easy for all to accomplish and equally easy to track and access. Such a world would work very well in the “new normal” when employees are frequently remote and unavailable for paper signatures. With Particle Measuring Systems’ PharmaIntegrity data management system you get a 21CFR11 compliant […]
Remote Audits in a New Normal World
Covid-19 has brought the need for tomorrow’s way of working crashing down on us today. This “new normal” means that many people will be working remote as frequently as possible. This presents challenges, including how to conduct an audit. Fortunately, there is one solution available today to solve this “new normal” problem when it comes […]
Particle Counter Data and Cleanroom Solutions in the New Normal: Part 1
Particle Counter Data Remote Access, 21CFR11 Electronic Signatures…. The new normal is here. Companies want to protect their employees, keep pharmaceutical manufacturing running, while working efficiently and effectively and getting product to market safely and quickly. This presents a wide range of challenges that we did not face at the beginning of 2020. Fortunately, Particle […]
Microbiological Plate Incubation and Pharmaceutical Risk Assessment
The new EU GMP Annex 1 draft, Rev 12 specifies the requirements of a pharmaceutical risk assessment to set appropriate microbiological plate conditions. This blog discusses this requirements to use a risk assessment, and then provides an interpretation on how to apply it and use it in different stages of the manufacturing process. There are […]
Cleanroom Monitoring per Annex 1 draft
Part 3 of 3 part blog on : Cleanroom Classification – Qualification – Monitoring Per EU GMP Annex 1, rev 12 draft There is little overlap with cleanroom monitoring and qualification and classification as seen in the image here: The goal of cleanroom monitoring is to assess the potential contamination risk of the product. […]
Cleanroom Qualification
Part 2 of 3 part blog on : Cleanroom Classification – Qualification – Monitoring Per EU GMP Annex 1, rev 12 draft The definition for Cleanroom Qualification is “The overall process to assess the level of compliance of a classified cleanroom with its intended use.” That is, classification is a part of qualification. Qualification methodologies […]
Cleanroom Classification
Part 1 of 3 part blog on : Cleanroom Classification – Qualification – Monitoring Per EU GMP Annex 1, rev 12 draft The latest Annex 1 draft has some new definitions and guidance regarding Cleanroom Classification, Qualification, and Monitoring. Cleanroom Classification Annex 1 provides essentially the same cleanroom classification definition as ISO 14644-1: 2015 which […]
How to Achieve Quality by Design (QbD) in a New Pharmaceutical Fill Line: Activity Organization (Series Part 6 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.
Cleanroom Process Risk Assessment per Annex 1
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 […]
