Two
important sets of documents, both of which shape the way control and monitoring
of contamination is handled within cleanrooms, are under review. These are
Annex 1 to EU
GMP, which relates to the manufacture of sterile medicinal products, and ISO
14698, which is a two-part standard serving as a multi-industry
biocontamination control guide.
Tim
Sandle has reviewed the forthcoming changes in the current edition of Clean Air
and Containment Review. The reference is:
For a copy, please contact Tim Sandle
Posted by Tim Sandle
No comments:
Post a Comment
Pharmaceutical Microbiology Resources