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.
Related: Deviation in Pharmaceutical Industry
