Home - Prequalification: Information for Applicants
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Guidelines for drafting a Site Master File (SMF) and a Contract Organization Master File (CROMF)
Layout of the SMF Annex 14 on WHO Guidelines for drafting a site master file (SMF), has been adopted in the latest Technical Report Series (TRS) 961. Although the SMF has been in place for a number of years, the current WHO format on SMF was aligned with the new PIC/S format and is in-line with the intent to harmonize internationally.
Layout of the CROMF Annex 7 on WHO guidelines for the preparation of a contract research organization master file (CROMF), has been incorporated in the Technical Report Series (TRS) 957. A CROMF is a document prepared by the contract research organization (CRO) containing specific and factual information about the conduct of clinical studies as well as the analyses of samples and related operations (including clinical trials, clinical data management, pharmacokinetics and statistical analysis and regulatory affairs) carried out at the site.
The applicants are recommended to use the current format and submit on a CD or DVD their SMF and/or CROMF for each manufacturing site of Finished Pharmaceutical Products (FPP) and/or Active Pharmaceutical Ingredients (API) and/or Contract Research Organization Master File (CROMF) respectively to:
Dr Deus Mubangizi |
