For a number of years, discrepancy and failure investigations within the pharmaceutical industry have been populating the Top 3 of a Food and Drug Administration (FDA) Observation list.
Unfortunately, this distinguished list depicts the top reasons why a 483 or warning letter would be issued to a company. Essentially, the FDA is stating that either companies are not investigating discrepancies and failures or their investigations are undoubtedly deficient on a consistent basis. In an earlier blog entitled Five Most Common Mistakes When Writing an Investigation, the author noted that the commonly identified mistakes for investigations are close-minded investigations, failing to identify and/or execute the appropriate CAPA, incomplete investigations, poorly written investigations, and inadequate Quality Impact Assessment.
Throughout my fairly extensive career, I’ve written and reviewed many investigations and, through the process, retained a few basic principles or “best practices.” Whether it’s investigating a roof leak into a manufacturing suite, a missed in-process time check, a differential pressure alarm, or an insect found in a lab,these same practices apply.
Here are a few of the easiest ones to adopt:
Investigations should be stand-alone (not leveraging another document), thorough, and objective.
Root cause and contributing factors should be identified and adequately supported.
Corrections and corrective and preventive actions (CAPAs)should be aligned with the root cause identified and appropriate.
Historical searches performed should be clearly defined and include search criteria (i.e., key words).
Product quality impact should be clearly detailed, fully evaluated, and documented.
Regardless if you are writing or reviewing company investigations within the pharmaceutical or any other industry, keeping these principles in view and making them best practices will, without a doubt, remove your company from the FDAs “premier” Observation list.
1. Five Most Common Mistakes When Writing an Investigation – ProPharma Group blog, 12/17/2015
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