The Food and Drug Administration (FDA) released a draft guidance on the Request for Quality Metrics on July 29, 2015 and it is open for comment through September 29, 2015. The following summary provides a simplified review of the draft guidance and its impact to industry.
Quality metrics are used throughout the pharmaceutical industry to monitor quality control systems and processes and drive continuous improvement efforts in drug manufacturing. These metrics can also be used by FDA for several reasons: to help develop compliance and inspection policies and practices, such as risk-based inspection scheduling of drug manufacturers; to improve the Agency’s ability to predict, and therefore possibly mitigate, future drug shortages; and to encourage the pharmaceutical industry to implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing.
The draft guidance outlines FDA’s authority under section 704 of the FD&C Act to require manufacturers to provide quality metrics, the data that the Agency plans to request, the uses FDA intends to make of the requested data, and the quality metrics that FDA intends to calculate.
PROPOSED USES OF QUALITY METRICS
Risk-Based Inspection Scheduling
With the release of the Food and Drug Administration Safety and Innovation Act (FDASIA) in 2012, the FDA replaced the previous two-year drug inspectional frequency requirement with a risk-based inspection schedule for both domestic and foreign drug facilities. The FDA intends to use quality metrics for determining the overall risk associated with a manufacturing establishment and/or product to guide the scheduling of inspections and the allocation of inspection resources.
Prediction of Drug Shortages
Taking action to reduce drug shortages remains a top priority for the FDA. The Agency has found that the majority of drug shortages stem from quality concerns—substandard manufacturing facilities or processes are discovered or significant quality defects are identified in finished product, necessitating an interruption in production and a shortage of drugs.
FDA intends to use quality metrics, in part, as a tool to identify factors that could potentially be predictive of drug supply disruption.
QUALITY DATA AND CALCULATION OF QUALITY METRICS
FDA intends to request the following data by product and establishment. The data will be used by the FDA to calculate four key metrics; 1) Lot Acceptance Rate, 2) Product Quality Complaint Rate, 3) Invalidated Out of Specification Rate, 4) Annual Product Review or Project Quality Review on Time Rate.
Proposed Requested Quality Data
- Number of Lots Attempted
- Number of Lots Rejected
- Number of Tests Conducted
- Number of Out of Specification (OOS) Results
- Number of Invalidated OOS Results
- Number of Product Quality Complaints
- Number of Lots Released
- Number of Annual Product Review or Product Quality Review completed within 30 days of due date
In addition, the FDA is requesting public comment on whether to give establishments the opportunity to submit additional, optional metrics as evidence of manufacturing robustness and a commitment to quality. Data from these optional metrics could be used to establish a reduction in inspection frequency.
FDA expects that the initial use of the requested quality data will be the establishment of objective metrics to guide inspection frequency and for determining the appropriate reporting category for post-approval manufacturing changes.
Furthermore, the FDA intends to use the quality data collected as one of the key factors in identifying establishments that may pose significant risks to consumers, such as risks from unsafe products and drug shortages.
To read the guidance in its original format, please click here.
Halloran Consulting Group