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As we’ve heard since 2013, the FDA will soon require quality metrics to be submitted for certain product types. There is no better summary of what the FDA hopes to achieve, than a quote taken from an FDA PowerPoint:

“A maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drug products without extensive regulatory oversight.”

Source: http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM374192.pdf

With this effort, the FDA hopes to improve product quality and prevent drug shortages. The FDA’s proposal highlights quarterly data gathered with an annual submission process. As of now, the FDA is still seeking comments until the end of the month, so updates are expected soon!   Submission of this data will occur through an FDA database portal. We will hear more regarding their plan to move forward with the collection of quality metrics soon and will blog about it on our site.

What metrics will be collected?

We’ve compiled a list of quality metrics that the FDA is looking to collect in this program. You can read more about this in the FDA’s draft guidance document from July of 2015. Some of these will start off as optional metrics.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM455957.pdf

  • Was each APR or PQR reviewed and approved by the following:
    • (1) the head of the quality unit
    • (2) the head of the operations unit
    • (3) both
    • (4) neither
  • What percentage of corrective actions involved re-training of personnel (i.e., a root cause of the deviation is lack of adequate training)?
  • Did the establishment’s management calculate a process capability or performance index for each critical quality attribute (CQA) as part of that product’s APR or PQR.
  • Did the establishment’s management have a policy of requiring a corrective action or preventive action (CAPA) at some lower process capability or performance index.
    • If “yes” to the above question – What is the process capability or performance index that triggers a CAPA?
  • # of Lots Attempted
  • # of Lots Rejected
  • # of Tests Conducted
  • # of OOS Results
  • # of Invalidated OOS Results
  • # Product Quality Complaints
  • # of Lots Released
  • Was the APR generated within 30 Days of annual due date?– (Yes or No)
  • How many APR’s or PQR’s are associated with the product?

Isn’t most of this submitted in the Annual Product Review?

A lot of the data listed above is submitted in the Annual Product Review. However, the APR doesn’t include a review of every batch, and information isn’t always broken down in a manner that can help identify issues or trends before they result in product loss. The proposed quality metrics program will ideally provide information to the FDA to help promote their risk-based inspection efforts triggered by the Food and Drug Administration Safety and Innovation Act (FDASIA).

Due to the fact that the FDA has published a draft guidance well in advance of implementation, those affected can be prepared. So, what can companies do to prepare for reporting these quality metrics? One way is to start to capture this data electronically in robust systems. This will help to reduce the reporting burden and also generate a faster response time to correct any issues, which is the ultimate goal of reducing product shortages.

For more information on Managing Compliance Risks with EAM/CMMS, view our recorded webinar.