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Our GMP Documentation training course covers the practical day-to-day implementation of Good Manufacturing Practice requirements for documentation and records; including the current EU and USA GMP ...

Both the USA cGMP 1 and EU GMP 2 dictate that cleanroom classification must be carried out according to ISO 14644-1. The version of this ISO standard released in 1999 4 was rewritten by a group of ...

An optimal engineering design is crucial for aseptic operation and cleaning. The first draft of the European Union (EU) good manufacturing practice (GMP) Annex 1, “Manufacture of Sterile Medicinal ...