Category: Regulatory

NewsUSP 1116 Quality Risk Management

BLOG: USP 1116 Commonly Asked Questions

Welcome to ourĀ USP 1116 questions and answers blog, where Particle Measuring Systems answers commonly asked questions pertaining to the USP 1116 guidance. What guidance is there for non-sterile facilities in regards to CRR (aseptic processing)? It is important to note that <1116> is a ā€œgeneral informationā€ chapter, and as such,…

NewsUSP 788 vs 1788

BLOG: USP 788 vs 1788: How do They Compare?

Why the USP 1788 update? New flow imaging technologies and therapeutic protein solutions widened the scope of USP 1788. Three primary technologies are discussed in each of the sub-parts of the guidance document: Light Obscuration (LO)Ā is still the preferred first-pass method for the USP Normative chapters. If a solution is…

NewsContinuous Monitoring Concept

FAQ’s: Class D Particle Monitoring Requirements

Question:Ā ā€œCan you speak to the requirements for monitoring Class D clean areas for viable and nonviable particulate. The regulations donā€™t make it black and white.ā€

NewsAnnex 1 compliant continuous microbial monitoring solution EU GMP Annex 1

EU GMP Annex 1 – Commonly Asked Questions

Welcome to ourĀ EU GMP Annex 1Ā questions and answers blog, where experts answers commonly asked questions about the latest changes to regulation.

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