|
|
Article: Cleaning validation needs to be broader, Perrigo told.(a pre-approval inspection at Perrigo plant)(Brief Article)
- Article from:
- Validation Times
- Article date:
- April 1, 1999
CopyrightCOPYRIGHT 1999 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
|
A pre-approval inspection for two over-the-counter ANDAs at Perrigo's Allegan, MI, plant paid close attention to how the company validated equip-ment cleaning, although process validation also was in progress during the audit. The applications were for ibuprofen oral suspension and miconazole nitrate vaginal cream.
No 483 resulted from the March 1997 audit, but the investigators raised some questions after reviewing the protocol and data for the cleaning validations, which were still under way. FDA did not identify the field staff that led the audit.
For the ibuprofen suspension, FDA noted that when hot water was unavailable, the company might substitute ...