Globepharm Consulting ‚ÌGMPŠÖ˜A‹Æ–±‚Ì‚²ˆÄ“à


EU requirements for site master file@Wed. 10 Feb. 2010


Dear Colleagues:

In December 2009, the EMEA proposed that a new informational Part III of the EU GMP Guide be created for documents which are not themselves GMP guidelines and have no statutory force but which complement the GMP guidelines and related regulatory procedures such as, in this case, inspections. It is expected that in the future, further documents will be added to the new Part III and that such documents would be included following public consultation.

Attached please find the first document that is to be added to Part III of the EU GMPs: a guideline describing the requirements for Site Master Files.
(The document is identical to the content of the PIC/S Site Master File and is published in parallel).
We at Globepharm strive mightily to keep abreast of developments in GMPs that occur world-wide. If you ever have any questions, please do not hesitate to contact me. As you know we specialize in GMP gap analyses and GMP training, if we can be of assistance please do not hesitate to contact us. We are scheduled to be in Vietnam in February, Hungary in March, Australia and Russia in April, India and Israel in May, Denmark and Switzerland in June and Brazil in October; we can relatively easily add an extra day or two on our way to, or from, these assignments to assist in enabling you to maximize your budget by sharing trans-oceanic travel costs.

With Best Regards,

Michael Anisfeld
Globepharm

Attachment :EMEA0912-Site Master File Guidelines







‚¨\‚µž‚ݐæF
“ú–{‘‘㗝“X
Š”Ž®‰ïŽÐƒeƒNƒgƒ‰ƒ“
“d˜bF0551-20-5530
FAX: 0551-20-5531
e-mail: info@techtran.co.jp
‘ã•\Žæ’÷–ðŽÐ’·F–q–ì•ó—¯