EMEA Publishes Set of Auditing Documents for Joint Audit Programme

GMP News No. 922: EMEA Publishes Set of Auditing Documents for Joint Audit Programme

GMP News
12 March 2007
 

EMEA Publishes Set of Auditing Documents for Joint Audit Programme

 
The Joint Audit Programme (JAP) was established by the Group of GMP inspection services (The EMEA provides coordinating support for the programme). The scope of the Joint Audit Programme is to verify the implementation of relevant provisions of European Directives into national law and covers all EEA GMP inspectorates in the field of human and veterinary medicinal products.

This programme is an important piece of the quality system adopted by GMP inspectorates and should help ensuring consistency of GMP standards and a harmonised approach throughout Europe: "The enlarged European Economic Area (EEA) with around 40 GMP inspectorates emphasises the need for a consistent approach. Joint audits are expected to lead to an improvement of the assessed authorities and allow the possibility that national auditors can transfer experiences gained during the audits to their national inspectorates. Mutual confidence among European inspectors is therefore established and maintained through these joint visits."

In order to avoid duplication of work, JAP strived for co-operation with PIC/S and the MRA. EEA, PIC/S and MRA audit programmes now use the same evaluation guide and they agreed on sharing outcome from visits.

The audit programme with its procedures and templates below form the complete set of documents used in the Joint Audit Programme:

  • Programme
  • Procedure
  • Audit plan
  • Audit notification
  • Audit checklist
  • Audit report
  • Confidentiality agreement for audits
  • CV template for auditors
  • Procedure for observing inspections
  • Observed inspection checklist

This set can be found on the EMEA website.
  

Learn more about inspections, audits and related topics in the following ECA courses:


Prague, Czech Republic, on 3-4 May 2007
 
  • How to Pass EU and FDA Inspections – GMP-Compliance Auditor Course
    Vienna, Austria, from 29-31 October 2007
  •  
    Prepared by:
    Wolfgang Schmitt
    On behalf of the European Compliance Academy (ECA)
      

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