Preparation of Site Master File

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

This SOP is applicable for the preparation of the Site master file.

QA Personnel, Head QA

  • A site Master File (SMF) is a written document, which provide the authenticate information about a manufacturing facility for whom it has been 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 finalize after the 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:
  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 recalls
  9. Self Inspection

PEOPLE ALSO READ: Good Laboratory Practice

  • The 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 manufactured at the site.

  • A list of the key personnel including their responsibilities, qualification and experience should be mentioned. Medical checkup and it schedules 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 explain.

  • 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 equipment and laboratory instruments shall be described including their details as an 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 be explained. Any special areas for handling of highly toxic hazardous and sensitizing material should be clearly addressed.

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

  • 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.

  • 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.

  • Details of the 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, product recall and handling of market complaint policy and procedure to be mentioned here by given cross reference of SOP. 
  • Wherever applicable a cross reference of Sops shall be given in SMF. As attachments of SMF shall be Layouts, list of key personnel, equipment/instrument/utilities list, manufacturing procedure flow charts, AHUs & water system layouts, site plan, civil layouts by highlighting areas, SOPs list, organograms and whatever required shall be attached as per SMF annexure.
  • Review and Up-dation of SMF: All changes have been done, shall update in SMF after a frequent interval or change record shall be tentatively maintained and at the time of revision all change shall be incorporated.
  • The review period shall be two years. After revision, document revision no. shall be revised.

SOP: Standard Operating Procedure
Q.A.: Quality Assurance
cGLP: Current Good Laboratories Practice
GMP: Good Manufacturing Practice


Revision History

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