SOP for Preparation of Site Master File

Objective

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

Scope

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

Responsibility

QA Personnel, Head QA

Procedure

• A site Master File (SMF) is a written document, which provides authenticated information about a manufacturing facility for whom it has been prepared and concerned.
• Site Master File shall have a unique document no. the format of the Site master file shall be fixed when first time prepared.
• SMF Preparation and Approval: SMF shall initiate from project and finalize it after the completion of the facility and startup of work it shall finalize.
• The SMF shall be prepared by QA personnel, checked by the Plant head, and approved by QA Head.
• The contents of SMF shall be as under: It includes the 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

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• 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.

PERSONNEL

• A list of the key personnel including their responsibilities, qualifications, and experience should be mentioned. Medical checkups 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. The evaluation method of training must be explained.

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

DOCUMENTATION

• 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.

PRODUCTION

• Flow charts of all drug manufacturing procedures shall elaborate on their Production process controls should be described. Ma & Material handling, movement during manufacturing process shall be written. The document should detail the arrangements for the 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, and 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 the contract agreement which states the policies regarding the supply of materials, testing, manufacturing process controls, packaging, and final dispatch of the product shall be detailed. 

DISTRIBUTION COMPLAINTS AND PRODUCT RECALL

• Distribution, product recall, and handling of market complaint policy and procedure are to be mentioned here by giving cross reference of SOP. 
• Wherever applicable a cross reference of Sops shall be given in SMF. As attachments of SMF shall be Layouts, a list of key personnel, equipment/instrument/utility 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, and shall be updated in SMF after a frequent interval or the change record shall be tentatively maintained and at the time of revision all changes shall be incorporated.
• The review period shall be two years. After revision, document revision no. shall be revised.

Abbreviation

SOP: Standard Operating Procedure

Q.A.: Quality Assurance

cGLP: Current Good Laboratories Practice

GMP: Good Manufacturing Practice

Annexure

Nil

Revision History

Nil

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