Procedure for Review and Approval of Site Master File (SMF)

1.0 Procedure

After the SMF is prepared in accordance with the guidelines then it is reviewed and approved for its further use. The procedure for maintaining the site master file (SMF) is given as follows

1.1 Review

A SMF Document coordinator is assigned by the QA department head that ensures that the SMF is prepared according to the guidelines

SMF Document coordinator prepares the content data by taking insights from designated departments in accordance with the guidelines and later sends it to the reviewing department. The document is reviewed for accuracy & completeness.

1.2 Approval

SMF Document coordinator sends the documents to the approvers and approvers can either reject or accept the SMF document.

If the SMF is rejected then it is notified to the SMF Document coordinator and after addressing the concerns it is redirected to the approvers

Finally when the document is approved then SMF Document coordinator must ensure it is in compliance with the standard operating procedures and a copy of the document is provided to the competent authority

1.3 Decision analysis 

Preparation and reviewing of the SMF is a complex task which is done with proper coordination and resources.

Following criteria should be considered when taking decisions on SMF

• Inspection process optimization
• Ensuring QA by self-inspection
• Co-operation of the departments involved
• Balance of cost and resources
• International harmonized site presentation

For a company with global operations the competent authority requests SMF in connection with the international marketing authorizations or import activities then it mandates SMF.

Review and approval, site master file (smf), decision analysis