Tag: pharmaceutical manufacturing

Newscontamination control strategy for a fill line cleanroom contamination sources

Cleanroom Contamination Sources

In our previous blog in this series, we introduced you to the contamination control strategy (CCS), and why you need one. This time, we look at the quality risk management approach to preparing the CCS in order to design the ideal cleanroom for your Pharma process.

Build the Ideal Contamination Control Strategy CCS

The CCS is designed to ensure quality risk management is built into every pharmaceutical process from the ground up, and every quality decision made has a foundation in scientific reasoning.

NewsCleanroom Monitoring

Cleanroom Monitoring System per Annex 1 draft

Cleanroom Monitoring v. Classification v. Cleanroom Qualification 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 a cleanroom monitoring system is to assess the potential contamination risk of the product. The…

NewsContinuous Monitoring Concept

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 Systemsā€™ Advisory Services Team. Our team has over 70 years of collective experience working in and advising cleanroom users around the world.

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