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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.

Take control of your impurities testing

5 October 2018 | By PerkinElmer

The control of impurities plays a crucial role in Pharma QA/QC and can be divided in 3 main buckets: Organic, Inorganic and Residual Solvents.  On this webinar we are focusing on analytical techniques used for control of Inorganic impurities and Residual Solvents...

Understanding current CFR 21.11 and data integrity requirements

8 August 2018 | By SUEZ

The US FDA and European Commission have defined regulations relating to the submission of electronic records in lieu of paper documents, for submission, inspection, and archiving purposes. When ageing analytical equipment is to be replaced 21CFR Part 11 and EU Annex 11 are also topics of discussion. Common questions from…