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Neptune Life Sciences. SITE MASTER FILE. CHAPTER. INDEX. PAGE. 3.4. 3.5. 3.6. 3.7. 3.8. 3.9. 3.10. Special area for handling of highly toxic hazardous and. 6 Jun 2011 A Site Master File (SMF) is a document prepared by a manufacturer that provides specific, factual information about the production and co. SITE MASTER FILE .. Compliance with GMP guidelines and applying the highest international standards warranting the quality of Environmental Guidelines. WHO format (used in the prequalification of products) harmonised with the PIC/S format for SMFs. Guidelines for drafting site master file and the contents in it are included in the following article. 1.1 The site master file (SMF) is prepared by the pharmaceutical manufacturer and should contain specific information about the quality management policies and activities of the site, the production and/or quality control of pharmaceutical manufacturing operations carried out at the named site and any closely 1.1 The Site Master File is prepared by the pharmaceutical manufacturer and should contain specific information about the quality management policies and activities of the site, the production and/or quality control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated A SMF is a document prepared by the manufacturer containing specific and factual good manufacturing practice (GMP) information about the production and/or control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. 23 Jun 2017 To write a guideline for preparing Site master File (SMF). Scope. This Sop is applicable for preparation of Site master file. ResponsibilitySee how write a site master file for pharma industery as contents, how much pages should be in an ideal SMF, self inspection in site master file.