Good manufacturing practices for sterile pharmaceutical products
Introductory note:
This document is a revision of section 17 of Part Three of “Good manufacturing practices [GMP] for pharmaceutical products” (1), which emphasizes specific points for the manufacture of sterile preparations to minimize the risks of microbiological, particulate and pyrogen contamination. It is not exhaustive in character, and some technical requirements may change in line with developments in the field of GMP or advances in engineering design.
1. General considerations:
1.1 The production of sterile preparations should be carried out in clean areas, entry to which should be through airlocks for personnel and/or for equipment and materials. Clean areas should be maintained to an appropriate standard of cleanliness and supplied with air that has passed through filters of the required efficiency.
See pdf below for complete guidelines:
WHO TRS (Technical Report Series) 902, 2002 Annex 6: pdf
