New FDA Guidance for Industry: Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP

GMP News No. 679

GMP News
28 February 2006
 
New FDA Guidance for Industry: Formal Dispute Resolution:
Scientific and Technical Issues Related to Pharmaceutical CGMP
 
For manufacturers of medicinal products for human use (including biologics, APIs) and for veterinary use, the FDA published a new guidance presenting the formal contact with the Agency in case of disagreement on scientific or technical cGMP questions in January 2006. Situations of the kind might arise especially during inspections or during the evaluation of inspection results at the Agency. This guidance document does not cover administrative questions or issues regarding medical devices or foods.

This guidance is a complement to existing documents on differences with the Agency, e.g. "21 CFR 10.75, Internal Agency Review of Decisions" and the CDER/CBER guidance for industry "Formal Dispute Resolution: Appeals Above the Division Level".

Content of the Guidance

Generally, the Agency suggests and recommends that discrepancies be cleared up together with the inspector on site during the inspection and before a 483 form is handed over.

For all disagreements that are too complex or time-consuming to be dispelled on site, the document introduces a 2-tier dispute resolution process for clarification with the Agency:

Tier One: Here, the addressees are the "Office of Regulatory Affairs (ORA)" and the "Center Levels"

Who is the right addressee? That depends on several factors:

  • for US-based manufacturers of medicinal products for human or veterinary use, the addressee is the competent "District Office"
  • for non-US-based manufacturers of medicinal products for human or veterinary use, it is the "Division of Field Investigations"
  • for US-based as well as non-US-based manufacturers of biologics, it is the "Office of Enforcement"

Objections should be made to the authority in writing within 30 calendar days after receipt of the 483 form. The manufacturer should provide the authority in question with all arguments and supporting documentation. The respective ORA unit evaluates the entries and can hear further authority representatives, who do not necessarily have to be involved in the process. The authority will then send a written response back within 30 calendar days.

In case the Agency accepts the objections, the answer will be a letter or an addendum to a 483 form. The result will be communicated internally and also prepared for discussion.

If the Agency does not accept the objections, the manufacturer can initiate tier two in case of disagreement with the Agency's decision.

Tier Two: Here the addressee is the "Dispute Resolution (DR) Panel on Scientific and Technical Issues"

The DR Panel consists of representatives of the "program centers" and of ORA as well as the Chair of the "FDA Council on Pharmaceutical Quality".

The manufacturer has to hand in the written objection against the tier-1 decision within 60 days after issuance of the tier-one decision. The DR Panel evaluates the objection in a session where it can hear internal and external specialists as well as attorneys of the Office of Chief Counsel (OCC). A response will be given within 30 days after this session and also communicated internally and externally.

Furthermore, the Guidance includes formal information on the process and a list of addresses of the respective authorities. Apart from that, examples for the 4 different areas demonstrate which issues are appropriate for the "Dispute Resolution Process":

  • Failure to Comply With a Precise Element of CGMP Regulations
  • Failure to Comply With a Precise Requirement Established in an Approved Application
  • The Regulatory Significance of Failing to Comply With a Precise Requirement
  • Issues Not Raised During the Inspection

By the way, all information relating to the described "Dispute Resolution Process" is available to the public within the framework of the Freedom of Information (FOI).
 

Current FDA requirements are dealt with at the following events:

- Out-of-Specification Results, Vienna, Austria, 27-28 March 2006

- FDA's and ICH'S New Quality Systems Approach, Prague, Czech Republic, 1-2 June 2006

 
Author:
Dr Andreas Mangel
on behalf of ECA

Source:
Guidance for Industry: Formal dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
 

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