With the FDA and the other regulatory authorities becoming more and more stringent in the expectation of their corrective and preventive action (CAPA), especially in the pharmaceutical sector; it is necessary for companies to be adhering to standards and reporting or eliminating nonconformities. They have to take utmost care in ensuring that these elements areidentified, fully investigated to their root cause and properly assessed:

  • deviations/non-conformance
  • annual product reviews
  • external and internal audit observations
  • product complaints
  • recommendations
  • regulatory issues

The way to do this is to have a Standard Operating Procedure (SOP) in place. According to the International Conference on Harmonization (ICH), SOPs are “detailed, written instructions to achieve uniformity of the performance of a specific function”.

Purpose of a CAPA SOP

The purpose of a CAPA SOP is to establish a system for the recording and capture of data for the purpose of analyzing it for trends, and then work on them for continuous improvement. It should consist of Corrections, Corrective action, Investigation(s) and Root Cause(s) determination. It should also take into consideration the impact on inventory; preventive actions; verification/validation; change control; success evaluation; monitoring effectiveness and review by senior management and follow-on activities.

Who does it?

The SOP should be headed and driven by the senior management, and should percolate to all departments. The senior management should not only make SOPs; they must also be responsible for implementing and reviewing it periodically.


The flow of an SOP is always subjective and depends on the intuition and comfort level of the manager. Generally, a senior manager could think of the following flowchart:

  • Complaints
  • Non-Conforming Material Report (NCMR)
  • Trends
  • Audits

While these above could be the “start and end” of the process; the following could be the activities taken up for SOP:

  • Initiation of Computer Assisted Report (CAR)
  • Perform Root Cause Analysis (CAR)
  • Estimate and record failure
  • Determine the CAPA that needs to be taken
  • Verification and Validation CAPA
  • Record order of changes.

After these, analysis needs to be made taking the following action points:

  • Has the problem been fixed?
  • Does it need to be monitored?

Of course, this is only a thumb rule. As mentioned earlier, there exist several ways by which a CAPA SOP can be carried out; this is just a sample.


Contact Detail

Phone: 800-447-9407
Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

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