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Good Manufacturing Practice (GMP)

 

Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorisation and licensing for manufacture and sale of drug products and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.

Understanding current CFR 21.11 and data integrity requirements

8 August 2018 | By SUEZ

Data integrity and 21 CFR Part 11/EU Annex 11 requirements are hot topics when ageing analytical equipment is to be replaced. Common questions from pharma and biopharmaceutical manufacturers include: is the new technology compliant with auditor expectations? Can we get the right data saved the right way in the right…

Understanding ISO Standards: ISO 14644-2:2015 Cleanroom Monitoring

19 January 2017 | By Particle Measuring Systems

ISO 14644-2:2015 is not only a new standard with which to be compliant, but is also a beneficial tool to use in achieving mature cleanroom environmental control. This webinar provides a review of the changes and how they affect your environment monitoring...

Wickham Labs to Exhibit at Pharmig 2016

3 November 2016 | By Wickham Laboratories Limited

Wickham Laboratories will be on Stand 8 at the 24th Annual Pharmig Conference in the Nottingham Belfry Hotel, November 16th & 17th...

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