Site master file


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The manufacturer should prepare a succinct document in the form of a ‘Site Master File,’ containing specific and factual GMP about the production and/or control of pharmaceutical manufacturing procedures carried out at the premises. It should contain the descriptions of the following:

General information:

  • Brief information on the firm
  • Pharmaceutical manufacturing activities, as permitted by the licensing authority
  • Other manufacturing activities, if any, carried out on the premises
  • Type of products licensed for manufacture, with flowcharts detailing procedure and process flow
  • Number of employees engaged in the production, quality control, storage and distribution
  • Use of outside scientific, analytical, or other technical assistance in relation to manufacture and analysis
  • Short description of the quality management system of the firm
  • Products details registered with foreign countries


  • Organizational chart showing the arrangements for quality assurance, including production and quality control
  • Qualification, experience, and responsibilities of key personnel


  • Simple plan or description of manufacturing areas drawn to scale
  • Nature of construction and fixtures/fittings
  • Brief description of ventilation systems. More details should be given for critical areas with potential risk of airborne contamination (schematic drawing of systems). Classification of the rooms used for the manufacture of sterile products should be mentioned.
  • Special areas for the handling of highly toxic, hazardous, and sensitizing materials.
  • Brief description of the water system (schematic drawings of systems), including sanitation.
  • Description of planned preventive maintenance programs for premises and of the recording system.


  • Brief description of major equipment used in production and in the quality control laboratories (a list of equipment required)
  • Description of planned preventive maintenance programs for equipment and of the recording system
  • Qualification and calibration, including the recording systems, and arrangements for computerized systems validation


  • Written specifications and procedures for cleaning manufacturing areas and equipment


  • Arrangements for the preparation, revision, and distribution of documents
  • Necessary documentation for the manufacture
  • Any other documentation related to product quality that is not mentioned elsewhere (e.g., regarding microbiological control of air and water)


  • Brief description of production operations using, wherever possible, flow sheets and charts specifying important parameters
  • Arrangements for the handling of starting materials, packaging materials, and bulk and finished products; this includes the arrangements for sampling, quarantine, release, and storage.
  • Arrangements for the handling of rejected materials and products.
  • Brief description of the general policy for process validation.

Quality control:

  • Description of the quality control system and of the activities of the quality control department. Procedures for the release of the finished products.

Loan license manufacture and licensee:

  • Description of the way in which compliance with GMP by the loan licensee should be assessed.

Distribution, complaints, and product recall:

  • Arrangements and recording system for distribution
  • Arrangements for the handling of complaints and product recalls

Self inspection:

  • Short description of the self-inspection system, indicating whether an independent and experienced external expert is to be involved in evaluating the manufacturer’s compliance with GMP in all aspects of production

Export of drugs

  • Products exported to different countries
  • Complaints and product recall, if any

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