Pharmaceutical Site Master File (SMF)

What is SMF?

Site Master File is Full information about the site.
Site Master file is a document that summarises the firm’s overall philosophy, intentions and approach to be used for establishing registration in various countries.

Which Guideline follow for preparation of SMF?

PIC/S and EU Guideline (Eudralex Volume-4), WHO TRS 961(Annex-14)

Preparation

SMF is Prepared by Quality Assurance and Reviewed by Plant Head and Authorised by Head QA.

Contents of SMF

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

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.

Storage Period

Site Master File shall be store by QA department for 10 years.