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Article: Firms can give FDA validation protocol to avoid 3-lot hassles. (Process validation).
- Article from:
- Validation Times
- Article date:
- May 1, 2000
- Author:
CopyrightCOPYRIGHT 2000 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)
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NEWARK -- Manufacturers should ask FDA inspectors during a pre-approval audit to examine drug validation protocols in order to obviate any changes before three-lot validation is performed.
That's the advice of Nancy Rolli, a New Jersey district investigator, who handles many drug GMP and preapproval audits.
She told NAPM's mid-year meeting May 16 that firms should not be gun-shy about asking the FDA inspector to examine the protocol--if one is available--"because it's a lot easier to have them review it before you've done any work."
Rolli said this protocol should include not only a flow chart of the process but be specific in describing ...
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