Standard Operating Procedure for Site Master File (SMF)


Site Master File

1. Purpose

To provide a standard operating procedure for preparation and approval of Site Master File (SMF).

2. Scope

The scope of this SOP is applicable for the preparation and approval of the Site Master File (SMF) at [company name].

3. Responsibility

Quality Assurance Person: To prepare the Site Master File
Plant Head: To review the Site Master File
Head Quality Assurance: To review the Site Master File
Corporate Quality Assurance Head: To approve the Site Master File

4. Definitions

Site Master File (SMF): The purpose of the Site Master File (SMF) is to provide an outline of Good Manufacturing (GMP) operations carried out at the manufacturing facility. The document covers the details of control implemented in the facility with respect to pharmaceutical manufacturing, processing, packaging, or holding operations carried out. The document also covers the information regarding adjacent areas that what types of facilities and operations are available in nearby buildings.

5. Procedure

  1. Site Master File is a document, which provides clear information on the GMP-related activities of [company name].
  2. The Site Master File shall be assigned with a unique document number as follows:
    DOC/SMF/001
  3. Content of Site Master File:Site Master File shall contain a minimum of the following information:
    1. General Information on the Manufacturer: Give the details under the following headings:
      • Brief information of the organization:
        This section covers the brief information and history about the organization, regulatory approvals, other locations of an organization, and activities carried out at each organization’s site.
      • Pharmaceutical manufacturing activities as permitted by the licensing authority:
        The document section provides information regarding the types of manufacturing activities permitted to be carried out in the facility. This may include the type of molecules handled in the facility, types of dosage forms, etc.
      • Other manufacturing activity, if any, carried out on the premises:
        The document section covers details regarding any other manufacturing operations (other than pharmaceutical operations) carried out at the premises.
      • Name of an organization, address, and contact details about telephone number, fax number, and 24 hrs telephone numbers:
        In this section of the document, the organization needs to provide a piece of information such as the Name of an organization, Full address of the site, Registered office location, telephone numbers, fax number and 24 hours telephone numbers, and other contact information.
      • Type of actual products manufactured:
        In this section, provide the details of the product being manufactured at the location. Declare information regarding hazardous or toxic substances which are handled at the site. If such materials are handled, controls provided in the facility while handling the material and manufacturing need to be explained.
      • Brief description of the site:
        This section needs to provide information regarding the facility’s size, location, and immediate environment, and other manufacturing activities on the site.
      • Number of employees:
        Provide the details regarding the number of employees engaged in various departments such as quality assurance, production, store, quality control, and distribution. The section also covers information regarding the usage of the contractual workforce involved in the GMP operation.
      • Use of contact operations to support manufacturing or laboratory operations in relation to product manufacture and analysis:
        Provide information regarding external contract laboratory for analytical and technical assistance concerning manufacturer and analysis. It shall include the Address, Phone Number, Fax Number, and E-mail Id. The service will include but not be limited to testing, calibration, validation, pest control, etc.
      • A brief explanation of the Quality Management System (QMS) of the organization:
        Provide information about Quality Management System followed by manufacturing site. It contains a Quality Policy, responsibility for quality functions. Explain briefly about quality system, audit programs systems demonstrating the adequacy of the quality system.
      • Quality Risk Management (QRM):
        Give a brief description of QRM methodologies used by the firm.  
    2. Personnel: Give the details of personnel in the organization as follows:
      • Organizational chart:
        Provide an organization chart showing arrangements of the different departments in the organization and its reporting structure.
      • Qualification, experience, and responsibilities of key personnel:
        Tabulate the details of key personnel’s name, education qualification, years of experience, title, and responsibility in an organization.
      • Training program and maintenance of training record:
        Provide details for various training such as induction training, CGMP training, annual training programs, mandatory training for all employees, etc.
      • Health requirement for personnel engaged in the various operations in the manufacturing facility:
        Outline the minimum health requirement of the personnel working in the manufacturing facility.
      • Personnel hygiene requirements:
        Provide details of required personnel hygiene of employees working in the organization.
    3. Premises: Explain about facility with the following details:
      • Plot plan and description of manufacturing areas with an indication of scale:
        Provide information of facility area with the indication of scale. Provide an area in Meter Square.
      • Details of construction design:
        Provide information about material of construction of the manufacturing building including walls, floor, ceilings and details utility installed and equipment orientation.
      • Brief description of ventilation system:
        Provide details of types of ventilation system installed in the facility. The information includes information regarding the level and sequence of filters used in the system.
      • Details about the critical areas with potential risk of airborne contamination and special areas for the handling of highly hazardous, toxic, and sensitizing materials:
        Provide information on the handling of highly toxic, hazardous, and sensitizing materials at the site.
      • Brief summary of water system design and sanitization program:
        Detail information regarding the water system available at the site. The details shall cover the water generation system, sanitization of the generation system, and the distribution system.
      • Planned preventive maintenance program for the facility and the documentation system:
        Describe preventive maintenance program implemented for premises, equipment, and instrument in the facility. Provide brief information about the breakdown maintenance program.
    4. Equipment:
      Explain about production and utility equipment as follows:
      • Equipment used in production facility:
        Provide details of major equipment available in the production facility. Also, detail about instruments available in the chemical and microbiology laboratory.
      • Qualification, validation, and calibration, including the recording systems and arrangements for computerized system validation:
        Explain the site’s qualification, validation, and calibration policy for equipment and instrument. Provide brief regarding software validation program and details of major computerized systems.
    5. Sanitization process in the facility:
      Provide the information regarding the sanitization process implemented for the premises, manufacturing area, and utility and its frequency.
    6. Documentation:
      The section covers details of arrangements made for preparation, revision, and distribution of necessary documentation for the manufacture and other documentation related to product quality that is not mentioned elsewhere in this SMF.
    7. Production: Explain the production system as follows:
      • Production operations and process flow:
        Provide details about how manufacturing operations are carried out and types of documentation required to record the details of operations.
      • Handling and storage of starting materials, packaging materials, semi-finish and finished product:
        Provide details regarding Raw Material and Packaging Material management. Explain the segregation strategies of the materials. Explain how the traceability of the materials are maintained up to the shelf life of the product.
      • Handling of rejected materials and product:
        Summarize the storage of Rejected Materials and product. Explain the destruction process of the rejected materials.
      • Policy for process performance verification or process validation:
        Provide information related to the validation policy adopted by an organization.
    8. Quality Control: Give the details under the following heading:
      • Information regarding laboratory system and release procedure:
        Provide information regarding laboratory operations at the site. It shall cover details regarding the resting and release of raw material, packing material, and finished product.
    9. Loan license manufacture and licensee: This section covers information regarding loan licensing activity from the manufacturing facility.
    10. Distribution, customer complaints, and recalls: This section covers details regarding the distribution of finished products, handling customer complaints, and return and recalls.
      • Distribution management:
        Give details related to the distribution of the finished product.
      • Handling of complaints, market returns, and product recall:
        Provide details regarding the process of handling customer complaints, categorization of complaints, and closing the complaints. The section also covers details regarding product return and product recall, investigation, and recall effectiveness.
    11. Self-Inspection: Provide the details about the self-inspection program implemented in the organization. The description should cover the process of identifying the non-conformance and verifying the compliance within the target completion date determined by the cross-functional team.
    12. Abbreviations and acronyms:
      This section of the document covers abbreviations and acronyms covered in the SMF.
    13. Attachments: Enlist the attachments to the Site Master File. Typical attachments are as follows:
      • Copy of valid manufacturing license
      • Copy of valid GMP certificate of the facility
      • Name and address of contract laboratories
      • List of GMP inspection carried out in last five years
      • Organizational chart
      • List of key personnel with designation, qualification, experience, and responsibilities
      • Approved Layouts of the facility
      • Schematic of typical HVAC system
      • Schematic of compressed air and dust extractor
      • Engineering drawing of the water system
      • List of major equipment available in the production facility
      • List of major instruments available in the laboratory
      • Typical process flow charts
    14. Revision history: This section covers revision details and related change control Nos. and effective dates of the previous version of SMF.
  4. Site Master File shall be revised once in three years.
  5. If there is any change in the attachment and it does not impact the main content, it can be revised separately as an amendment.

6. Frequency

  • Every three years
  • Any major change in the system requires the content update

7. Formats

Format for Site Master File

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