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Prepare SMF

The site master file should contain specific information about the quality   management policies and activities of the site, the production and/or quality control of pharmaceutical manufacturing operations carried out at the named site and any   closely integrated operations at adjacent and nearby buildings.

For example, the content of SMF could be as follows:


1 General information on the manufacturer

1.1   Contact information on the manufacturer

1.2   Authorized pharmaceutical manufacturing activities of the site

1.3   Any other manufacturing activities carried out on the site

2 Quality management system of the manufacturer

2.1   The quality management system of the manufacturer

2.2   Release procedure of finished products

2.3   Management of suppliers and contractors

2.4   Quality Risk Management

2.5   Product Quality Reviews

3 Personnel

4 Premises and Equipment

4.1 Premises

4.1.1   Brief Description of HVAC system

4.1.2 Brief Description of Water System

4.1.3 Brief description of other relevant utilities

4.2 Equipment

4.2.1 List of major production and control laboratory equipment

4.2.2 Cleaning and sanitation

4.2.3   Computerized systems

5 Documentation

6 Production

6.1   Type of products

6.2   Process validation

6.3   Material management and warehousing

7 Quality Control

8 Distribution, Complaints, Product defects and Recalls

8.1   Distribution

8.2   Complaints, product defects and recalls

9 Self inspections

10 Appendix

Add:402, Building 23, No.588, Xinjunhuan Rd. Minhang, Shanghai 201114, CN

Post Code:201114 Tel:021-50911366 Fax:021-50911377