qbd
[PDF] A critical look at Annex 1: Manufacture of Sterile Medicinal ... - QbD
December 20, 2017. The guideline has significantly grown, from 16 to at least 50 pages ... g) Vendor approval – such as key component suppliers, sterilization of ... The current guideline only speaks about air circulation, HEPA filtering of the ... For APS, a sterile nutrient media and/or placebo, with the ability to imitate product ...
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