what is deviation in pharma
Deviation in pharma means any departure from an approved process, procedure, specification, or standard. In simple terms, it is when something in manufacturing, testing, packaging, storage, or documentation does not go exactly as expected.
Quick Scoop
A deviation can be:
- Unplanned , such as a machine malfunction or an operator error.
- Planned , if a temporary, approved change is made in advance in some quality systems.
Why it matters
Deviations matter because they can affect:
- Product quality
- Patient safety
- Regulatory compliance
Common examples
Examples include:
- Using the wrong raw material.
- Not following an SOP.
- A process step being performed outside the specified limit.
- A testing result falling outside the expected range.
What happens after a deviation
In pharma, deviations are usually:
- Documented.
- Investigated to find the root cause.
- Assessed for impact.
- Closed with corrective and preventive actions, if needed.
If you want, I can also explain the difference between deviation, nonconformance, and CAPA in pharma.