New CAPA Guidance Published

CAPA (Corrective Action Preventive Action) and failure investigation become more and more important for the pharmaceutical industry. This becomes clear in a series of guidance documents. Above all with the ICH Q10 document, CAPA was introduced as a new quality-assuring tool. This document states e. g. that a pharmaceutical company should have a system in place for taking corrective and preventive measures (CAPA). These can, among other things, result from complaints, deviations, recalls, observations in audits and inspections or monitoring results. The investigations within the system should aim at finding the actual cause. The outcome should be that process and product are better understood and improvements are derived. The inspectors, too, take account of this fact; e. g. in the warning letters of Fiscal Year 2008, most of the observations listed referred to deficiencies in the handling of deviations. But the European inspectorates also place increasing emphasis on successfully established CAPA processes.

Now the European Commission has published a proposal for the revision of Chapter 1 of the EU GMP Guide in order to implement the contents of ICH Q10 (see GMP News from 13 January 2010).
Here one can now find a detailed description of the call for a CAPA procedure. However, it does not offer any concrete instructions for the implementation. Here, a newly proposed Guidance by the GHTF* can help:

In this document the CAPA system is described as an integral part of the Quality Management System (QMS) and consists of 4 phases:

  • Phase I: Planning
    - Planning for Measurement, Analysis and Improvement Processes
    - Establish Data Sources and Criteria
  • Phase II: Measurement and Analysis within and across Data Sources
    - Measurement
    - Analysis
  • Phase III: Improvement
    - Investigate
    - Identify Root Cause
    - Identify Action
    - Verification of identified action
    - Implement Actions
    - Determine Effectiveness of Implemented Actions
  • Phase IV: Input to Management
    - Reporting to Management
    - Management Review

These phases are described in detail, in addition an appendix lists corresponding activities. Another appendix lists examples of sources of data that can find entrance into a CAPA system. A third appendix includes a checklist of items that should be considered in case of failure investigation.

Even though proposed for manufacturers of medical devices, this document gives comprehensive suggestions on how a pharmaceutical company, too, can implement a functioning CAPA system.

*GHTF = Global Harmonisation Task Force; voluntary international association of representatives from health authorities and the medical device industry. It consists of representatives from the EU, the USA, Canada, Japan and Australia. It is the objective of the GHTF to bring about a harmonisation between the systems, e. g. through the creation and publication of guidance documents that can be used as a basis for the creation or modification of new bills.

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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