FDA to Revise Draft Guidance on Quality Metrics Data

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Monday offered a couple of revisions to its list of guidance documents for 2016. Most notably, a revision to the agency’s draft guidance on quality metrics is expected later this year.

The revision on the quality metrics data draft comes as FDA has received 79 comments on the first draft released in July 2015, and as many at the PDA/FDA Joint Regulatory Conference on Monday in Washington, DC, noted heightened interest in the types of metrics data FDA is requesting and what the revisions will entail.

In June, FDA released a technical reference document with recommendations to pharmaceutical companies on the submission of records and other information to support FDA’s calculation of quality metrics as part of the process validation lifecycle and pharmaceutical quality system (PQS) assessment.

According to that document, the agency is seeking information on:

• Product quality complaints received for drugs distributed in the US
• The number of lots attempted that are released for distribution or for the next stage of manufacturing for the finished drug product or active pharmaceutical ingredient (API)
• Whether the Annual Product Review (APR)/Product Quality Review (PQR) was performed within 30 days of the annual due date
• The number of specification-related lots rejected for the drug referenced
• The number of lots attempted pending disposition for more than 30 days on the last day of the time period within which the data being reported was collected
• The number of test results that fall outside the specifications or acceptance criteria for the drug
• The number of lot release and stability tests conducted for the drug
• The number of invalidated out of specification (OOS) results for finished drug product or API and stability tests due to laboratory error for the drug

Comments on the technical guide are due 26 September.

In addition to the revised metrics guidance, the agency also added a guidance to its plate: “Comparative Analyses of the Device Constituent of a Drug-Device Combination Product Submitted in an ANDA,” according to the updated guidance agenda.