1.0 SITE MASTER FILE (SMF)
1.1 What is Site Master File SMF
SMF is detail information about the site. it is abbreviated as SMF
SMF is a document that summarizes the firm’s overall philosophy, intentions and approach to
be used for establishing registration in various countries. It is also referred as drug master file in event it is submitted to regulatory agency for approval of a drug.
See here What is Drug master file.
1.2 Which Guideline follow for preparation of SMF
PIC/S and EU Guideline (Eudralex Volume-4).
1.3 Preparation of Site Master File.
SMF is Prepared by Quality Assurance and Reviewed by Plant Head and Authorized by Head QA.
1.4 Contents of Site Master File
- General Information
- Personnel
- Premises and Equipment
- Documentation
- Production
- Quality Control
- Contract Manufacture and Analysis
- Distribution, Complaints and Product Recall.
- Self Inspection
1.5 Review Period
Any changes after approval of SMF shall be recorded in Annexure-II for keeping a track of changes taken place. All such changes shall be collated and amended in the next revision.
Site Master File shall be revised at end of every calendar year or as and when required through change control management system
1.6 Storage Period of a Site Master File
SMF shall be store by QA department for 10 years.