FDA Guide to Inspections of Lyophilisation of Parenterals, July 1993
Title:
FDA Guide to Inspections of Lyophilisation of Parenterals, July 1993
Origin/Publisher:
Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA
Document Type:
FDA Guide to Inspection
Content:
These guidelines of ORA within FDA are not addressed to the industry but to the FDA inspectors. The Guides to Inspection are, however, a useful guide. Here you will find guidelines for the inspection of lyophilized parenterals.