In this article you will find the answers of following questions:

  • What is deviation in pharmaceutical industry?
  • What are causes of deviation?
  • How many types of deviation are there in pharma?
  • What are the examples of deviation in pharma?
  • What is deviation investigation procedure?
  • What is the difference between deviation and CAPA?
  • What is a deviation report?
  • How do you handle pharma deviation?


Deviation

Deviation is an unexpected event that occurs during the on-going operation or activity and documentation or practice that differs from the approved processes, procedures, instructions, specifications, or established standards at any stage of receipt, manufacturing, storage, sampling and testing of raw materials, intermediates, drug products and packing materials. 

Deviation in a pharma industry is a very common but unexpected incident. It may arise from human error, equipment failure, raw material problem, inappropriate documentation, process unknown etc.  When a deviation is occurred it should be reported and to be investigated for impact assessment on product quality and patient safety.


Types of deviation

In general, there are three types of deviation in pharma: critical, major and minor. Where critical deviation that have significant impact on the product quality or GMP system, major deviation have a moderate to considerable impact on the product quality or GMP system and minor deviation unlikely to have a detectable impact on product quality or GMP system.

For details: Different Types of Deviation in Pharmaceutical Industry


Examples of deviation

Critical: Product mix-up and cross contamination, missing a process step during manufacturing, filter integrity failure etc.

Major: mixing order change, machine breakdown etc.

Minor: room condition doesn’t meet, spillage of material during dispensing etc.


Investigation procedures

5 steps way for a deviation investigation are -

1. Incident discovered and documented within 1 business day

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

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

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

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

For details: Investigation of GMP and GDP Deviation


Deviation vs CAPA

Deviation is a departure from a documented or standard procedure or process, where corrective Actions are taken to eliminate the root causes of deviations, and should be based on good quality investigations. In addition, manufacturers are strongly recommended to identify preventive actions which are proactive in nature and prevent the recurrence of the problem (preventative actions).


Deviation handling

The process flow of deviation handling -

1. Event Detection

2. Deviation Categorization (Major/Minor, Planned/Unplanned)

3. QRM initiation

4. Root cause investigation

5. CAPA

For details: Deviation Handling and Quality Risk Management


Deviation report

A report containing investigation details, outcome, corrective and preventive actions and conclusion.