Help the FDA help you
Be sure to provide complete information about your facilities, including but not limited to the FDA establishment identifier
number, correct street address of the actual manufacturing plant, the name and number of a contact person at each plant, and
the exact function of the facility in the context of the drug application. All facilities should be submitted in one section
of the application, so that they are easy to locate for the reviewer. Also, a quick response to the agency's queries can reduce
guessing time spent on a submission and earn quick feedback from the FDA.
Cooperation is also key. Good team players help each other accomplish their goals by respectfully listening to each other's
point of view and without taking antagonistic positions. Working together accelerates review and ensures approvals of qualified
products on time.
Put it in writing
Finally, the FDA recommends having written agreements with contractors that identify: 1) the locations to be used for manufacture;
2) the responsibilities of each participant; 3) the specific product shipped to the contract facility; 4) the manner and conditions
of shipment; 5) product segregation SOPs; 6) a commitment to inform the license holder of errors and deviations; and 7) how
and when the contract facility will be audited. Regulatory actions with legal consequences can be easily avoided with a well-written
One of the FDA's goals is to facilitate product development and manufacturing flexibility, and therefore, it supports advancement
of new and innovative ways that will lower the cost of drug development while advancing the critical path for a drug product's
review. Providing guidance to manufacturing firms on different types of outsourcing and recommending how to improve their
submissions is one more way the FDA shows support for this goal.
This article was written by Marlene Garcia Swider in her private capacity. No official support or endorsement by the Food
and Drug Administration is intended or should be inferred.
Marlene Garcia Swider, MHSA, is a regulatory project manager in the division of gastroenterology products at CDER, FDA, Silver Spring, MD, 301.796.2104,
1. US Food and Drug Administration. Guidance for Industry. Quality systems approach to pharmaceutical CGMP regulations. Rockville,
MD; 2006 Sept. Available from:
2. US Food and Drug Administration. Guidance for Industry. Cooperative manufacturing arrangements for licensed biologics/
Rockville, MD; 2008 Nov. Available from: