This graphic used in the CAPA GMP Review page is the city of Montreal Skyline.

Introduction to CAPA

Are CAPA Reviews being regularly used?  If so; why is it that Corrective and Prevention action procedures continue to be a major source of 483 observations. The majority of companies claim to have fully functioning systems in use and yet FDA audits regularly find these systems are either partially or incorrectly used.  How can companies proactively address these regulatory deficiencies?

CAPA Review Rationale.

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The FDA and regulators world-wide require manufacturers of pharmaceutical, biological and medical devices not only to have a procedure (CAPA) in use; but to regularly execute reviews that will identify,  instigate investigation, and report on deficient or failure within the system. These compliance reviews and all relevant records of compliance verification should be retain for regulatory review.  

Having such a system recording and instigating investigation into all reported defects not only helps companies fulfill their regulatory obligations, but also helps prevent new problems from arising, and known problems from re-occurring.  Poor CAPA systems remain one of the top problem areas for both the drug and device industries when it comes to FDA inspections. And citations account for more than 50 percent of FDA warning letters.

This CAPA review document has been prepared to enable your system to be easily assessed for compliance with the requirements.  As part of the CAPA functionality, individual users complete action tasks by providing input and/or results, and managers approve the overall CAPA process. Similarly, the CAPA review process enables quality managers to schedule audits and track their progress and results. Individual contributors can provide responses, enabling the entire team to multi-task and facilitate an in-progress review. Quality Improvement Central is intended to provide a powerful, yet simple solution for managing quality while maintaining tight process inter-operability with other aspects of the product life-cycle.


Management Involvement.

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Management must ensure and be involved in a review and confirmation that actions taken were effective and did not introduce new issues or concerns. The following questions should be considered at appropriate times throughout the process and be revisited in the final review:

  • Has the problem been comprehensively identified?
  • Have the root cause/contributing factors of the problem been identified and  addressed?
  • Has the improvement action(s) been defined, planned, documented, verified and implemented?

    CAPA Defined (ICH Q9 & 10)

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    A structured approach to the investigation process should be used with the objective of determining the root cause.

    The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk, in line with ICH Q9.

    CAPA methodology should result in product and process improvements and enhanced product and process understanding.

    Please note.

    ICH Q9 & Q10; are not intended to create any new expectations beyond current regulatory requirements. Consequently, the content of ICH Q9 & 10 that are additional to current regional Good Manufacturing Practice (cGMP) requirements are optional.


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    Computer Combined IQ-OQ-PQ (Issue 3) -- $159.00

    This combination protocol has been produced in response to several hundred reader suggestions we received in our ‘Suggestions Section’. It has been carefully designed to make it the preferred choice for Process and Laboratory stand-alone equipment qualification. It is interactive, easy to use and suitable for all mixes of equipment with and without software.

    Computer User Requirements Specification (Issue 5.) -- $115.00

    The document that sets the standard, and specifies your computer requirements in a manner that ensures when a system or piece of equipment is selected, it will deliver the functions you want, it will have maintenance standards, it will have calibration records, it will have all the documents and records to enable successful equipment qualification to be completed. This document was designed to be used as a live document up until the DQ is completed and approved.

    Computer Validation Master Plan (Issue 5.) -- $115.00

    The Computer equipment qualification and Validation Master Plan, is the starting point for validation, and hence the most important validation document. It improves validation efficiency greatly by forcing all concerned to document, review, and discuss, the proposed methods and allotted responsibilities. It is an expected document with the FDA, and a mandated document with the EU.

    Computer Validation Package 1. (Issue1) -- $675.00

    This computer equipment qualification and validation package is suitable for all major validation projects and contains the under-listed interactive documents. VMP, VP, URS, VRA, DQ, IQ, OQ and PQ.

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