SOP on Guideline for Preparation of Site Master File



To write a guideline for preparing Site master File (SMF).


This Sop is applicable for preparation of Site master file.


QA Personnel

Head QA,


Site Master File (SMF) is a written document, which provide the authenticate information about a manufacturing facility for whom it has prepared and concerned. 

Site Master File shall have a unique document no. Format of Site master file shall fix when first time prepared.

SMF Preparation and Approval: SMF shall initiate from project and finalized after completion of facility and startup of work it shall finalize. The SMF shall be prepared by QA personnel, checked by Plant head and approved by QA Head.

The contents of SMF shall be as under : It includes following headings and then details under these:

  • General Information
  • Personnel
  • Premises and Equipment
  • Documentation
  • Production
  • Quality Control
  • Contract manufacture and analysis
  • Distribution, complaints and product recalls
  • Self Inspection

GENERAL INFORMATION: General information section of SMF shall include the brief information and description of the firm. Name and address of the site including the telephone, fax and electronic mail shall be mentioned. Quality Policy of the company and the quality management system shall be described.

Description of the firm shall detail with location and surroundings. The drugs which are manufacturing at the site.

PERSONNEL: A list of key personnel including their responsibilities, qualification and experience should be mentioned. Medical checkup and it schedule for personnel working in manufacturing core areas should be described.

Gowning procedure with their maintenance shall be described.

Training of personnel including from starting to continuity like Induction, cGMP, job-specific and external training shall be covered. Evaluation method of training is must to explain.

PREMISES AND EQUIPMENT: Entire details of Premises with MOC shall be explained by highlighting the areas (like manufacturing, eng., QA & QC etc.) in the layouts. A brief description of equipments and laboratory instruments shall be described including their details as annexure.

Preventive maintenance and Sanitization and Pest Control measures shall be included in the Site Master file.

All utilities like water, HVAC, compressed air, nitrogen gas facility including steam generator, chiller, and boiler shall describe with their capacity and for the HVAC & water system all related layouts shall explained. Any special areas for handling of highly toxic hazardous and sensitizing material should be clearly addressed.

DOCUMENTATION: This section shall detail the description of documentation & data control system. Documents related to product quality like Specifications, STPs other documented procedures shall be described under this section.

PRODUCTION: Flow charts of all drug manufacturing procedures shall elaborated with their Production process controls should be described. Ma & Material handling, movement during manufacturing process shall be written. Document should detail the arrangements for handling of rejected materials and finished products.

QUALITY CONTROL: Description of QC activities shall be detailed which shall include the preparation, revision and distribution of specifications, STPs, GTPs. Procedure & responsibility for review and release of batch. Handling of Out of Specification policy should be defined under this section.

CONTRACT MANUFACTURE AND ANALYSIS: Details of contract agreement which states the policies regarding the supply of materials, testing, manufacturing process controls, packaging and final dispatch of the product shall de detailed.

 DISTRIBUTION COMPLAINTS AND PRODUCT RECALL: Distribution, product recall and handling of market complaint policy and procedure to be mentioned here by given cross reference of SOP.

SELF INSPECTION: A self inspection schedule with procedure shall describe in this section.

Wherever applicable a cross reference of Sops shall be given in SMF. As attachments of SMF shall be Layouts, list of key personnel’s, equipment/instrument /utilities list, manufacturing procedure flow charts, AHUs & water system’s layouts, site plan, civil layouts by highlighting areas, SOPs list, organograms and whatever required shall attached as per SMF annexure.

Review and Up-dation of SMF: All changes has been done, shall updated in SMF after a frequent interval or change record shall be tentatively maintained and at the time of revision all change shall be incorporated.

 Review period shall be two years. After revision, document revision no. shall be revised.

Related articles:




Please enter your comment!
Please enter your name here