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Tuesday, August 9, 2011

Effects of the 2006 Proposed Revisions to Annex 1 of theEuropeanUnion Good Manufacturing Practices

Particularly in the fields of cleanroom technology and sterile products manufacturing, good manufacturing practices (GMPs) regulations and guidances and technical cleanroom standards are mutually dependent on each other. The classification of air cleanliness specified in the International Organization for Standardization (ISO) 14644-1:1999 (1, 2) is quoted as a tool in Annex 1 of the European Union (EU) GMPs (3) and in the US Food and Drug Administration's 2004 aseptic processing guidance (4). The mutual dependence of GMPs and cleanroom standards is clear in that the ISO cleanroom standards are not application specific. The standards don't advise which levels of cleanliness are applicable to specific processes. Similarly, the EU GMPs do not explain how to measure airborne contamination or how to classify a controlled environment.
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Gordon Farquharson
Pharmaceutical Technology, May 1, 2006


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