What are the possible causes for “Out of Specification”? : Pharmaceutical Guidelines

What are the possible causes for “Out of Specification”?


Out of specification is the deviation of the product from the pre-determined specification.
The following are the possible causes for out of specification:
  • Test analysis error in QC Lab.
  • Lab equipment malfunctioning or off-calibrated
  • Production equipment malfunctioning or off-calibrated
  • Operator/human errors



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