FDA Compliance Requirements for Deviation Investigations

FDA Compliance Requirements for Deviation Investigations

Elements of a Thorough FDA Pharma Deviation Investigation

A deviation is a measured difference between a normal or expected value and an observed value for a pharmaceutical product or process. It can also be a noted departure from a documented or standard procedure. These deviations can happen during manufacturing, sampling and testing, or during product acceptance. They can also come about as a result of customer complaints when a company’s standards do not meet the attributes they claim to deliver.

And the FDA takes deviations very seriously.

The FDA understands that deviations do occur, but it is still important to manage them correctly because the FDA requires that deviations be documented and investigated. These investigations should be led by the Quality Control Unit and conducted with the laboratory or operational department in a collaborative approach that provides subject expertise as well as objectivity.

Don’t fall short on meeting FDA criteria.

Final decisions on dispositions must be fully supportable and objective. Should the FDA determine that corrective and preventive action is necessary, it expects completion when opportunities are found to improve and/or revise procedures to prevent future deviations.

What should a thorough deviation investigation include in order to maintain FDA compliance?

These investigations usually should be completed within 30 days and contain the following:

  •         A Description of the Deviation: Descriptions should include the event, background, and a brief summary of any actions taken during the event. It should include how the event was identified and when the deviation began and ended. Information on how the event was limited or controlled should also be included.
  •         Summary of the Event: Be sure that a clear, concise statement about the deviation is included. This should only need to be a couple sentences long.
  •         Materials and Products Affected: Properly and thoroughly identify the scope of any and all materials or lots that have been affected and explain the rationale for identifying the impacted materials.
  •         Root Cause Investigation: This is a description of the hypotheses that tested potential root causes, the findings that don’t support any potential root causes, a description of the path that the investigation took, and the identification of the most probable root cause of the deviation.
  •         Impact Assessment: This is a concise, clear description of the impact the deviation has caused on product quality. It must include all lots affected and those that are potentially affected; this assessment must be scientifically valid and objective.
  •         Analysis of Trends: This analysis must address trends of deviation events and note if more in-depth subsequent investigations were or will be done. Recurring events and root causes must be completely analyzed to determine the effectiveness of any previous corrective and preventive actions taken, as well as the accuracy of the root cause of the deviations.
  •         Corrective and Preventive Actions (CAPA): This includes the identification and implementation of any corrective action and preventive actions that have been or will be taken; actions should address any and all root causes that have been identified.

Deviation investigation reports must provide evidence that fully supports findings, conclusions, and actions, and must always remain objective. The FDA will record failures to conduct thorough and timely deviation investigations, and if a pattern of failures is documented, the inspection will likely escalate to become an Official Action Indicated case, with aggressive compliance options pursued.

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By |2019-06-20T20:51:06+00:00May 12th, 2019|

About the Author:

Jonathan Gilde

Jonathan is a digital marketer based in San Diego. Whether developing a content marketing strategy for a Fortune 500 company or helping an emerging small business develop a brand, he’s passionate about delivering results.