The QMN Weekly Bulletin

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:

• The company’s organizational chart;
• Production floor diagrams showing room classifications;
• In-process and final product specifications;
• List of names and addresses of approved vendors, including testing facilities;
• Lists of all lots currently quarantined besides those awaiting initial routine testing;
• Outstanding complaints and adverse event reports;
• Failure investigations and process deviations;
• Resolved and unresolved out-of-specification results;
• Sterility and environmental failures and investigations; and
• Recalls.

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.

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