Site Master File
Dear All,
Thank you in advance for your answers regarding my question, which is: Do you have to present a Site Master File (SMF) upon inspection when the audit is an initial one for a pharmaceutical manufacturing facility which is not yet certified for complying with GMP?

Regards
5 Replies
Trish Borzon
841 Posts
HI Borislav Stoilov‍ - I'm tagging a few people here who might be able to help. Jeremiah Genest‍ , Stephanie Gaulding‍ , Lance Harding‍ , Duke Okes
Good Luck!
Trish
The Site Master File is a requirement in just about every set of pharmaceutical regulations except the US FDA for GMP operations and would be a fundamental expectation to receive a GMP certificate.

You should most certainly have one in place prior to your certification inspection and be prepared to provide it. Many regulators, in the case of scheduled inspections, will request it ahead of time.
Hello Trish Borzon,
Thank you very much for following my question and for your reply. Jeremiah Genest gave an answer to my enquiry.
Regards,
Borislav
Hello Jeremiah Genest,

Thank you, too for your answer and for making clear this particular question that I had. I must have indicated, however that my question relates to EU GMP regulations.
Regards,
Borislav Stoilov
Yes, any EU inspector will ask for the SMF in the first 10 minutes. It is a GMP requirement in the Eudralex, volume 4 Good Manufacturing Practices, chapter 4 "Documentation" Principle and in a bunch of other places. Definitely read the explanatory note on site master files at https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2011_site_master_file_en.pdf for all the details for management and content.