To supplement the draft guidance for industry on Request for Quality Metrics, The US FDA have released a Quality Metrics Technical Conformance Guide to recommend how quality data should be submitted. The document contains information on how the US FDA wishes to receive, process and archive electronic data files for the quality metrics initiative, including file name lengths, special characters allowed and other descriptors.
What elements are mandatory?
The document suggests how the content should be laid out and formatted, including applicant details, drug information, time periods and the mandatory metrics requested including:
- Lots attempted
- Lots Rejected
- Attempted Lots Pending Disposition
- Out of Specification (OOS) Results – Finished Drug Product or API
- Number of Lot Release and Stability Tests – Commercial Use
- Out of Specification (OOS) Results Invalidated
- Product Quality Complaints
- Lots Attempted and Released
- Annual Product Review (APR) / Product Quality Review (PQR) Completed
- Annual Product Review (APR) / Product Quality Review (PQR) Required
What are optional?
The document also details optional data elements including:
- APR Approval
- APR Approval by Quality Unit and/or Operations Unit
- Percentage of Corrective Actions and Preventive Actions (CAPA) Involving Retraining
- Process Capability (PC) or Process Performance (PP) Index Calculation
- CAPA Trigger Policy
- Triggers for CAPA
Data validation rules?
A chapter on data validation rules indicates that: “data validation is a process that attempts to ensure that submitted data are both compliant and useful. Compliant means the data conform to the applicable and required data standards. Useful means that the data support the intended use (i.e., regulatory review and analysis). Data validation is one method used to assess submission data quality“.
The US FDAs current thinking on Quality Metrics
At the recent ISPE Quality Manufacturing Conference that PharmOut attended in the US in June, Quality Metrics was one of the topic that received a lot of attention by the US FDA presenters. It was evident that the adoption of this initiative may be difficult for some companies.
Challenges identified included the fact that metrics are defined differently at different manufacturing sites, complicated supply chains and context can be different. The US FDA stance was that the metrics will ultimately protect patients, and this initiative will take effort from industry.
The data will help the agency to implement a risk-based inspection frequencies, detection of drug shortage issues, monitor site performance and encourage emerging technology.
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