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FDA requests submission of Quality Metrics Data for new signal detection program

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Katharine Miller

Lead Consultant, Genpact Pharmalink

September 8, 2017 - In November 2016, the U.S. Food and Drug Administration (FDA) released draft guidance signaling its intention to collect quality data from pharmaceutical companies and other manufactures involved in the process. 

What does the guidance cover? 

It outlines the FDA’s plan to start collecting and using quality data to improve its inspection policies and practices, help mitigate drug shortages and encourage better practices and processes in the pharmaceutical industry. 

The FDA wants to use the collected data to establish a signal detection program  to identify:

  • Manufacturers and products that may pose a risk to consumers
  • Situations that may hamper drug supply distribution

The quality metrics the agency intends to calculate are:

  • Lot Acceptance Rate (LAR): Indicator of manufacturing process performance
  • Product Quality Compliant Rate (PQCR): Indicator of patient or customer feedback
  • Invalidated Out-of-Scope Specification (OOS) Rate (IOOSR): Indicator of operation of a laboratory

The guidance outlines the acceptance criteria and ways of calculating these metrics. All of which are key indicators of the process quality used in manufacturing drugs.

How will this impact the way drugs are manufactured?

By collecting this data, the FDA hopes manufacturers will take a hard look at their processes and find ways to enhance them.

The industry already recognizes the importance of collecting quality data. But further initiatives like this, coming directly from the FDA, are likely to drive pharmaceutical manufacturers to implement Lean and Six Sigma process methodologies for continuous improvement. The FDA hopes this will encourage establishments to implement emerging technologies and report back on their effectiveness.

This is a step in the right direction for pharmaceutical manufacturers and will help drug companies improve their processes, fostering further advancements in the industry.


About Katharine Miller - Lead Consultant, Genpact Pharmalink

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