GHTF Publishes Auditing Guideline

GMP News
29 May 2008
 

GHTF Publishes Auditing Guideline

  
The Global Harmonisation Task Force (GHTF) is for the medical device sector more or less what ICH is for the pharmaceutical industry. Apart from industry and authority representatives from the founding members EU, USA, Japan, Canada and New Zealand, in the meantime further members have been admitted into the GHTF (e. g. Swissmedic). It is the objective of the GHTF to harmonise medical device regulations across the member organisations.

In order to reach this ambitious aim, the GHTF has issued a number of guidelines. Among them is a new guideline on the topic of Regulatory Auditing, which was published at the end of last year. The new Part 3 describes requirements on "Regulatory Audit Reports". So, the guideline gives recommendations on reporting within the framework of regulatory audits in the field of medical devices. However, the "Scope" expressly mentions other auditing organisations, too, not only authorities. The guideline defines a structure for audit reports in order to facilitate reporting for the auditors. Moreover, this approach is also meant to produce standardised audit reports. As a consequence, these reports will be easier to review and to exchange (between authorities). By standardising such (regulatory) audit reports, their acceptance is also meant to increase - and this idea is linked to the hope that some audits might even become unnecessary.

The document includes 11 pages, the first few of which list some general issues (e. g. the "Purpose") and clarifies definitions. On page 8, the interesting part starts: Here the main points of an audit report are explained concerning data on

  • the auditee
  • the audit
  • the audit trail
  • the conclusion, signatures and attachments.

Conclusion: The guideline is primarily directed at authorities auditing medical device manufacturers. However, it can be equally useful for other auditors in the medical device industry. In addition, it might also be of use to manufacturers of medicinal products or APIs who want to create a structure for an audit report for the first time or who intend to compare their existing report structure with an official document.

The document can be viewed at
http://www.ghtf.org/documents/sg4/sg4-n33-r16.pdf 

Author:
Sven Pommeranz
On behalf of ECA
 

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