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preclinical

FDA Issues Notice of Proposed Rulemaking Regarding 21 CFR Part 58, Good Laboratory Practice (GLP).

The proposed changes would affect all participants in GLP trials:  Sponsors, Testing Facilities and supporting laboratory services.  We encourage all affected parties to review and comment on the proposed changes.  The public comment period for the proposed changes closes November 22, 2016.  Details on the proposed changes and how to comment are available on the Federal Register website:  https://www.federalregister.gov/documents/2016/08/24/2016-19875/good-laboratory-practice-for-nonclinical-laboratory-studies

APS has conducted an in depth review of the proposed changes and concluded that the FDA is proposing significant changes to GLP’s.  These changes propose to formalize the GLP’s into a “complete Quality System”.  While this change is attractive in some regards, the resulting proposal will make compliance to the GLP’s more challenging as it moves the FDA from regulating individual study conduct towards regulating the operations, oversight and management of GLP compliant labs.  Proposed changes include:

  • Formal documentation of a Quality Policy and implementation of a formalized Quality Management System
  • Additional requirements to document USDA And Animal Welfare Act compliance
  • Additional documentation of review/oversight by: Sponsor, Executive Management, Test Site Management, Attending Vet, Quality Assurance
  • Validation of computerized systems and equipment
  • Auditing of reports and results when 3rd party non-GLP laboratory services are utilized

FDA has also included several sponsor-centric requirements in their new proposals.  FDA proposes to expand the scope of application to the GLP regulations to include all current FDA marketing permits and application types across all centers – not all filing types or applications currently require GLP compliance within the individual filing regulation or associated guidance.  In addition FDA proposes to require:

  • Documented qualification of test facilities including for GLP and AWA compliance
  • Formal documentation of transfers of “regulatory responsibilities” similar to those seen in clinical trials
  • Documentation and retention of communications with test sites and Study Directors
  • Submission requirements to include complete reports and to update filings with locations of archived materials post-submission

These and additional changes are proposed which could impact how sponsors and test facilities interact, contract, conduct and document GLP studies.  We encourage you and your respective company to review the proposed changes and evaluate potential impact to your operations.  We encourage all our clients and colleagues to provide feedback to the FDA on which changes are beneficial, reasonable and likely to improve preclinical research and which changes might create additional, redundant, or unreasonable burdens on your organization.  In addition, this is an opportunity to comment on other aspects of the GLP’s that might merit additional consideration by the agency as they seek to modernize.

To assist you, APS has materials available to speed up your review.  Please contact APS directly to request a condensed version of the proposed changes, a presentation highlighting new requirements and an overall analysis of the potential impact of these regulations.