What is a Site Master File?
PURPOSE OF SITE MASTER FILE
Site Master File is useful to the regulatory authority in Planning and Conducting GMP audits/ inspections.
"A document prepared by the Product Manufacturer 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."
Content of Site Master File
General information of the manufacturer
Contact information of 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.