What is Site Master File

What is Site Master File

A document prepared by the Product Manufacturer which provides specific, factual information about the production and control of manufacturing operations at the site. It also provides information about closely integrated operations nearby buildings.

Purpose of Site Master File

Site Master File is useful to the regulatory authority in Planning and Conducting GMP audits/ inspections.

Content of Site Master File

  • General information on the manufacturer
    • Contact information on the manufacturer.
    • Any other manufacturing activities carried out on the site.
    • Authorized pharmaceutical manufacturing activities of the site.
  • Quality management
    • The quality management system of the manufacturer.
    • Product quality reviews.
    • Quality risk management.
    • Management of suppliers and contractors.
    • Release procedure of finished products.
  • Personnel 
    • Organizational Chart.
    • Number of Employees engaged in all departments.
  • Premises and equipment
    • Brief description of heating, ventilation, and air-conditioning (HVAC) systems.
    • Brief description of water systems.
    • Brief description of other relevant utilities such as steam, compressed air, nitrogen, etc.
    • Cleaning and sanitation 
    • Good manufacturing practices critical computerized systems.
  • Documentation
    • Standard Operating Procedures
    • Specifications (Raw Material, Packing Material, Intermediate Product, Finished Product etc)
    • Records.
  • Production
    • Type of products.
    • Material management and warehousing.
    • Process validation.
  • Quality control
    • Activities of the Quality Control department
    • Activities of the Quality Assurance department.
  • Distribution, complaints, product defects, and recalls.
    • Distribution (to the part under the responsibility of the manufacturer).
    • Complaints, product defects, and recalls.
  • Self-inspections
    • Short description of the Self Inspection System.

Annexes to submission of a site master file

Annex 1:  Copy of valid manufacturing authorization 

Annex 2:  List of dosage forms manufactured including the International Nonproprietary Names (INN) or common name (as available) of APIs used 

Annex 3:  Copy of valid GMP certificate

Annex 4:  List of contract manufacturers and laboratories including the addresses and contact information, and flowcharts of the supply chains for these outsourced activities 

Annex 5:  Organizational charts 

Annex 6:  Layouts of production areas including material and personnel flows, general flowcharts of manufacturing processes of each product type (dosage form) 

Annex 7:  Schematic drawings of water systems 

Annex 8:  List of major production and laboratory equipment.