EMEAGCP inspection関係情報

2007/10/24現在

 

EMEAGCP inspection関係は次のページにまとまっており、PDFファイルで読むことが出来ます。

Inspections - Inspection procedures and guidance for GCP inspections conducted in the context of the Centralised Procedure

http://www.emea.europa.eu/Inspections/GCPproc.html

 

内容:

The GCP Inspectors Working Group has developed procedures for the coordination, preparation, conduct and reporting of GCP inspections carried out in the context of the Centralised Procedure.

These inspections are adopted by the CHMP and may be routine or may be triggered by issues arising during the assessment of the dossier or by other information such as previous inspection experience.

They are usually requested during the initial review of a Marketing Authorisation Application, but could arise post-authorisation (e.g. inspection of studies condcuted or completed as part of the condition of a marketing authorisation, or because of concerns arising about the studies previously submitted).

INS-GCP-3a3.pdf (Computerised Systems)はカバーページのみで次のようにありました。

The EU GCP inspectors agreed to use as the reference for inspection of Computer Systems the publication of the PIC/S – publication SB022 “Inspection of Computer Systems”. The hyperlink to the PIC/S site is http://www.picscheme.org/index.php

 

このサイトでpublication SB022 Inspection of Computer Systems”を探しましたがすぐ見つからず(SBSeminar Bookletsの略のようですが、ダウンロードは出来ず

The scientific content of Seminar booklets 001 to 027 is no longer valid. You can still order these booklets (subject to availability) if interested by their historical value. 

とありました)、代わりに

PI 011-3 PIC/S GUIDANCE (2007/9/25)
GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN REGULATED "GXP" ENVIRONMENTS
http://www.picscheme.org/publication.php?id=8 の下の方)

という文書(54ページあり、かなり詳細な文書になっています)があります。

また、 GMP GUIDANCEANNEX 11 "COMPUTERISED SYSTEMS"があります。

PI 009-9(ANNEXES) PIC/S GMP GUIDANCE (2009/9/1)
http://www.picscheme.org/publication.php?id=4 の下の方)