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?
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.
Thank you very much for following my question and for your reply. Jeremiah Genest gave an answer to my enquiry.
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.