|
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
|
