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Cleaning and Disinfection: the (newest) guidelines from Annex 1, rev 12

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The latest Annex 1 draft offers several updated expectations on cleaning, decontamination and disinfection. Definitions Cleaning (NEW)A process for removing contamination e.g. product residues and disinfectant residues. Decontamination The overall process of removal or reduction of any contaminants (chemical, waste, residue or microorganisms) from an area, object, or person. The method of decontamination (e.g. cleaning, […]

How to Achieve Quality by Design (QbD) in a new Pharmaceutical Fill Line: Intro and Regulatory (Series Part 1 of 6)

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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.

What are the newest Annex 1 Single Use Requirements and Does the BioCapt Single Use Impactor Meet Them?

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The new EU GMP Annex 1 rev 12 states, regarding single use: 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 are […]

It is possible for pharmaceutical quality to be the combination of Quality by Design (QbD) and current Good Manufacturing Practices (cGMP)?

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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

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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. […]