New GMP Annex1 and "Contamination Control Strategy"

New GMP Annex1 and "Contamination Control Strategy"

Do you know how to prepare a contamination control strategy document? Or how to create your contamination control strategy from scratch? If you don't, please join us to learn how to draft a proper contamination control strategy as per new GMP Annex1 2022.
New GMP Annex1 and Contamination Control Strategy   One of the most important news in the pharmaceutical industry from a regulatory standpoint was the New GMP Annex 1 revision in 2022. With more than a revision, 99 new paragraphs, and several new definitions, the new GMP Annex 1 becomes a completely new document for most of us.   Contamination Control Strategy (CCS) is one...

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How to Valdiate your Online Monitoring System?

How to Valdiate your Online Monitoring System?

Brief guide for proper validation steps and system specification of viable & non-viable monitoring system
  In previous article we covered details of design of a monitoring system. Especially current regulations, standards and helpful referances were captured in that article. This sequent article will cover monitoring system installation following with validation steps as per ISPE GAMP5.   About GAMP5…   GAMP is an acronym for Good Automated Manufacturing Practice, for a...

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About me

About me

General Manager, EMEA Lighthouse Worldwide Solutions Contamination Control - Cleanroom Design – Environmental Monitoring – Risk Assessment – Leadership – Management Hasim Solmaz is General Manager of Lighthouse Worldwide Solutions EMEA Operations. Hasim’s focus is on cleanroom design and management concepts, environmental monitoring systems, pharmaceutical...

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Best 3rd Wave Coffee Shops of Istanbul

Best 3rd Wave Coffee Shops of Istanbul

Here you can find a list of 3rd wave coffee shops, best barista places, boutique coffee shops, cupping and roasting places in Istanbul!
You can find a list of 3rd wave coffee shops, best barista places, boutique coffee shops, cupping and roasting places in Istanbul here in this list. List is still growing because I am still exploring Istanbul. Let's start!     Cumbalı Kahve 4.6           (270)   Coffee...

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