Tag: cleanroom monitoring

NewsData Analytics in Pharmaceutical Manufacturing

Data Analytics in Pharmaceutical Manufacturing

What Cleanroom Data Analytics in Pharmaceutical Manufacturing Should be Considered When Setting up Environmental Monitoring? Pharmaceutical Manufacturing Data Analytics and Managment is one of the important steps for effective contamination control In a typical pharmaceutical manufacturing plant, there are several important tasks to ensure the product can be handled without…

NewsCleanroom Qualification

Cleanroom Qualification

Cleanroom Qualification –Ā Classification ā€“ Monitoring Per EU GMP Annex 1, rev 12 draft The definition for Cleanroom Qualification is ā€œThe overall process to assess the level of compliance of a classified cleanroom with its intended use.ā€ That is, classification is a part of qualification. Qualification methodologies are identified in EU…

NewsCleanroom Classification Contamination Control Strategies

Cleanroom Classification

Cleanroom Classification ā€“ Qualification ā€“ Monitoring Per EU GMP Annex 1, rev 12 draft The latest EU GMP 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 is…

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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