Technical Reference Document Letter

On June 27, 2016, FDA announced in the Federal Register the issuance of a Technical Reference Document titled “Quality Metrics Technical Conformance Guide”. This Guide is meant to supplement the FDA Guidance titled “Request for Quality Metrics” in that it provides technical recommendations for the submission of quality metrics data called for in the Guidance. The Guide provides a line-by- line description of what FDA is looking for in each field, and also provides examples of what the reporting for each of the metrics should be. Lachman Consultants reviewed a copy of this guide in a recent blog on our website, titled “Technical Reference Guide Issued for Quality Metrics” (Published June 24, 2015). FDA is specifically requesting that the following information, other than information about the product, facility or applicant, be provided:

  • Lots Attempted
  • Lots Rejected
  • Attempted Lots pending disposition
  • Out of Specification Results – Finished Drug Product or API
  • Number of Lot Release and Stability Tests – Commercial Use
  • Out of Specification Results Invalidated
  • Product Quality Complaints
  • Lots attempted and released
  • Annual Product Review/Product Quality Review Completed
  • Annual Product Review/Product Quality Review Required
  • Annual Product Review Approval*
  • Annual Product Review Approval by Quality Unit and/or Operations Unit*
  • Percentage of CAPA Involving Retraining*
  • Process Capability (PC) or Process Performance (PP) Index*
  • CAPA Trigger Policy for PC or PP Index*
  • Triggers for CAPA*

* Optional Metrics

Comments on the new Technical Conformance Guide are due by September 26, 2016 and should be submitted to the docket FDA-2016- D-1594.

Even though both guidances are still in draft, FDA seems determined to collect a set of metrics from regulated firms. Lachman Consultant Services has a vast amount of experience in helping companies set up metrics programs. Make sure that you are prepared for this FDA initiative. Contact Lachman today to talk to someone about how we can help you.