Site Master File




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.

Site Master File
                                    What is Site Master File What is DMF

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

  1. General Information
  2. Personnel
  3. Premises and Equipment
  4. Documentation
  5. Production
  6. Quality Control
  7. Contract Manufacture and Analysis
  8. Distribution, Complaints and Product Recall.
  9. 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.

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