The Global Harmonisation Task Force (GHTF) is for the medical device sector moreor less what ICH is for the pharmaceutical industry. Apart from industry andauthority representatives from the founding members EU, USA, Japan, Canada andNew 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 deviceregulations across the member organisations.
In order to reach this ambitious aim, the GHTF has issued a number ofguidelines. 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 describesrequirements on "Regulatory Audit Reports". So, the guideline givesrecommendations on reporting within the framework of regulatory audits in thefield of medical devices. However, the "Scope" expressly mentions other auditingorganisations, too, not only authorities. The guideline defines a structure foraudit reports in order to facilitate reporting for the auditors. Moreover, thisapproach is also meant to produce standardised audit reports. As a consequence,these reports will be easier to review and to exchange (between authorities). Bystandardising such (regulatory) audit reports, their acceptance is also meant toincrease - and this idea is linked to the hope that some audits might evenbecome 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 partstarts: 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 authoritiesauditing medical device manufacturers. However, it can be equally useful forother auditors in the medical device industry. In addition, it might also be ofuse to manufacturers of medicinal products or APIs who want to create astructure for an audit report for the first time or who intend to compare theirexisting report structure with an official document.
The document can be viewed here.
On behalf of ECA