Guide to Good Manufacturing Practice
The rules governing medicinal products in the European Union were issued by the EU around the same time as ISO 14644 was first issued, and EU Pharmacopoeia became the benchmark for the manufacture of medicinal products. The directive laying down principles and guidelines of good manufacturing practice (GMP) for medicinal products for human use (Directive 91/356/EEC) was adopted by the Commission in 1991. Detailed guidelines in accordance with those principles are published in the Guide to Good Manufacturing Practice (EudraLex) which is used in assessing applications for Manufacturing Authorisations and as a basis for inspection of manufacturers of medicinal products by the Regulator. For the manufacture of sterile medicinal products there are 4 grades of clean ware specified
Areas, Grades A, B, C, & D.
In the original ISO 14644-4:2001 the guidance given for the maximum permitted number of particles in the “At Rest” condition corresponded approximately to the US Federal Standard 209E and the ISO 14644 classifications as follows: Grades A and B correspond with class 100, M 3.5, ISO5 Grade C with class 10.000, M 5.5, ISO 7 Grade D with class 100.000, M6.5, ISO 8 Hence Grade A, B, C and D facilities for the manufacture of medicinal products became inextricably linked to ISO 14644 cleanroom classifications and unfortunately tagged with ACR (Air Change Rates).
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