Deviation is very common incident in pharmaceutical industry. Here we mention 5 step process for GMP/GDP deviation investigations.


Step 1: Incident discovered and documented within 1 business day.


Step 2: The 5 W's (Who, What, When, Where, Why) must be answered.

  • Who discovered?
  • What happened?
  • When exactly did it happen?
  • Where exactly it happen?
  • Why did it happen or how did you discover it?


Step 3: Investigate with Subject Matter Experts (SME) and QA. Decide on whether a risk assessment must be performed.

  • Was the controlled document followed correctly?
  • Was there any error on the controlled document followed?
  • Is it possible to continue with the task despite the deviation?
  • Were there any similar deviation recorded?


Step 4: Perform the Root Cause Analysis (RCA) using, for example, the Fishbone investigation tool.

  • Was it document related?
  • Was it personnel related?
  • Was it equipment related?
  • Was it parameters related?
  • Was it material related?
  • Was it internal/external audit related?


Step 5: Conclude and close record. Cross reference any CAPA where applicable.

  • Summaries outcome of risk assessment on impact to product, regulatory and process.
  • What was the immediate action taken to resolve the incident?
  • If applicable initiate CAPA and provode CAPA ref. number.


Resource Person: Sanjay N.