FDA’s Quality Metrics Guidance for the Pharmaceutical Industry

In July of 2015 the FDA issued a draft of guidance, “Request for Quality Metrics” in order to monitor quality control in the pharmaceutical industry and drive continuous improvement efforts in drug manufacturing. This will help to develop compliance and inspection policies and practices such as risk based inspection scheduling. This guidance includes an explanation of how Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER ) will intend to collect data and use quality metrics to help and ensure that their practices and policies continue to support continuous improvement and innovation in the pharmaceutical manufacturing industry.


On the basis of these guidelines, FDA plans to use its authority to collect records “in advance of or in lieu of” an inspection, under section 704(a)(4)(A) of the FD&C Act to gather different quality metrics data records. FDA will use these records to further develop a risk-based inspection scheduling. For companies with robust quality metrics data, this information could be used to reduce the inspection frequency at an establishment or manufacturing premises. In cases where the data raises issues, FDA says that having the quality metrics data will allow it to “improve the efficiency and effectiveness” of the inspections.

FDA will request the following standard quality metrics from companies as part of its analysis:

  • Total number of lots attempted of the product.
  • Total number of specification-related rejected lots of the product, rejected during or after manufacturing.
  • Total number of attempted lots pending disposition for more than 30 days.
  • Total number of out-of-specification (OOS) results for the product, including stability testing.
  • Total number of lot release and stability tests conducted for the product.
  • Total number of OOS results for lot release and stability tests for the product which are invalidated due to lab error.
  • Total number of product quality complaints received for the product.
  • Total number of lots attempted which are released for distribution or for the next stage of manufacturing the product.


Let see how you can use Quality Metrics in your pharmaceutical manufacturing system.

Quality metrics can be used in three ways in FDA regulated industries:

  1. It can assist segment sites for risk-based inspection schedule such as required under FDASIA, Title VII and Section 705
  2. In assisting segment products (and/or processes) and individual product manufacturers based on risk.
  3. On the basis of basis of structured (objective) component of inspection and review.


To know more about FDA guidance on “Request for Quality Metrics” you may join this session on FDA Quality Metrics Guidance to be hosted on Wednesday, February 10, 2016 by expert speaker Dr. Jerry Lanese. The session will provide vital information to management personnel at all levels of a pharmaceutical organization. Attendees will be able to identify the required quality metrics and discuss its impacts on the pharmaceutical firm. They will also get a copy of FDA Quality Metrics guidance for easy reference.

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