Home > Newsletters > The QMN Weekly Bulletin > FDA Tells Drugmakers to Use Its Inspection Checklist on CMOs
The QMN Weekly Bulletin
Aug. 24, 2012 | Vol. 4 No. 34
FDA Tells Drugmakers to Use Its Inspection Checklist on CMOs
The FDA is giving drugmakers some key advice for qualifying and auditing contract manufacturers: Start by requesting the same documents the agency wants to see when it begins an audit.
CBER Investigator Pam Trost said a routine audit or qualification audit should start with a request for the following information:
Additionally, drugmakers should review the contract manufacturing organization’s standard operating procedures, quality management systems and the training and qualification of staff. “You may not get everything you ask for during an audit, but you can still ask,” Trost said.
When a contract manufacturer notices something unusual about your product — an unusual result, a change in raw materials supplier, a new piece of equipment or packaging — do they react the way you want?
Problems with a contract manufacturer or lab can emerge in dozens of unexpected places, and with FDAnews’ Managing Contract Manufacturers and Testing Labs you can have this comprehensive, step-by-step guide written by the foremost authorities in the pharmaceutical manufacturing field. Don’t wait, order your copy today.
ePublishing :: CMS, Hosting & Web Development | © Copyright by FDAnewsAll rights reserved. Do not duplicate or redistribute in any form.