|
|
Article: Final guidance for GMP inspection dispute resolution does not cover PAIs.
- Article from:
- Inspection Monitor
- Article date:
- February 1, 2006
- Author:
CopyrightCOPYRIGHT 2006 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)
|
FDA Jan. 11 released its final guidance titled "Guidance for Industry: Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP," which does not apply to pre-approval or pre-licensing inspections, and the agency noted that existing Center guidance would apply to those audits.
The purpose of the document is to provide guidance to manufacturers of veterinary and human drugs, including human biological drug products, on how to resolve disputes of scientific and technical issues relating to current GMP requirements, using a formal two-tiered dispute resolution process.
The guidance was issued because of disputes related to ...