ФДА (FDA) опубликовала проект руководящих принципов для промышленности озаглавленный “Request for Quality Metrics”

On 28 July 2015, FDA published a draft guidance for industry entitled “Request for Quality Metrics”. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.

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:

• to help develop compliance and inspection policies and practices, such as risk-based inspection scheduling of drug manufacturers, according to the known safety risks (i.e. the compliance history of the establishment; the record, history, and nature of recalls linked to the establishment) that could increase or decrease inspection frequency;
• to improve the Agency’s ability to predict, and therefore, possibly mitigate, future drug shortages (taking action to reduce drug shortages remains a top priority for FDA); and
• to encourage the pharmaceutical industry to implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing.

In addition, FDA intends to consider whether these metrics may provide a basis for FDA to use improved risk-based principles to determine the appropriate reporting category for post-approval manufacturing changes, with emphasis on encouraging lifecycle manufacturing improvement.

Under Title VII of the Food and Drug Administration Safety and Innovation Act (FDASIA) Public Law No. 112-144, FDA may require the submission of any records or other information that FDA may inspect under section 704 of the FD&C Act, in advance or in lieu of an inspection, by requesting the records or information from a person that owns or operates an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug product or an API used in the manufacture of that drug product, including i.e. contract laboratories, contract sterilizers, contract packagers.

FDA does not intend to publicly disclose quality metric data submissions.

Manufacturers can expect that reported quality data may be verified during on-site inspections. If inconsistencies are identified, the integrity of the report may be questioned and used as an additional factor in FDA risk-based or for-cause inspection scheduling.

The failure to report requested quality data may elevate an establishment’s predicted risk in FDA’s prioritization of inspections and may lead to an earlier inspection. In addition, products associated with an establishment that does not report as required may be deemed adulterated and subject to enforcement action.

FDA intends to ask industry to submit one report for each finished dosage form and one report for each API of a covered drug product.

FDA would ask for data to be aggregated and reported on:

• The number of lots attempted of the product.
• The number of specification-related rejected lots of the product, rejected during or after manufacturing.
• The number of attempted lots pending disposition for more than 30 days.
• The number of OOS results for the product, including stability testing.
• The number of lot release and stability tests conducted for the product.
• The number of OOS results for lot release and stability tests for the product which are invalidated due to lab error.
• The number of product quality complaints received for the product.
• The number of lots attempted which are released for distribution or for the next stage of manufacturing the product.
• If the associated APRs or PQRs were completed within 30 days of annual due date for the product.
• The number of APRs or PQRs required for the product.

Using reported data described above, FDA intends to calculate the following quality metrics for each product and establishment, where applicable:

• Lot Acceptance Rate = 1 – x (x = the number of specification-related rejected lots in a timeframe divided by the number of lots attempted by the same establishment in the same timeframe).
• Product Quality Complaint Rate = the number of product quality complaints received for the product divided by the total number of lots of the product released in the same timeframe.
• Invalidated Out-of-Specification (OOS) Rate = the number of OOS test results for the finished product invalidated by the establishment divided by the total number of OOS test results divided by the total number of tests performed by the establishment in the same timeframe.
• Annual Product Review (APR) or Product Quality Review (PQR) on Time Rate = the number of APRs or PQRs completed within 30 days of annual due date at the establishment divided by the number of products produced at the establishment.

FDA believes that these quality metrics, in conjunction with other data accessible to FDA (e.g., inspection results, recalls) provide important information about operational reliability and quality culture.

FDA intends to request submission of quality metrics data reports for a one-year period that begins after the Agency issues its requests, as specified in the request. Reports would be submitted within 60 days of the end date of the reporting period.

Once FDA receives information in response to requests, the Agency intends to issue a confirmation of receipt. Information included in quality metric data submissions should be submitted in English.

All details you will find in the draft guidance Request for Quality Metrics.