药品注册PMF包含内容

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1、Site Master File.1 General information:1.1 Brief information of the firm;1.2 Pharmaceutical manufacturing activities as permitted by the licensing authority;1.3 Other manufacturing activities, if any, carried out on the premises;1.4 Type of product licensed for manufacture with flow charts mentionin

2、g procedure and process flow;1.5 Number of employees engaged in the production, quality control, storage andDistribution;1.6 Use of outside scientific, analytical or other technical assistance in relation toManufacture and analysis;1.7 Short description of the Quality Management System of the firm;

3、and1.8 Products details registered with foreign countries.2 Personnel: 2.1 Organizational chart showing the arrangement for quality assurance includingProduction and quality control;2.2 Qualification, experience and responsibilities of key personnel;2.3 Outline for arrangements for basic and in-serv

4、ice training and how the records are maintained;2.4 Health requirements for personnel engaged in production; and2.5 Personal hygiene requirements, including clothing.3 Premises:3.1 Simple plan or description of manufacturing areas drawn to scale;3.2 Nature of construction and fixtures/fittings;3.3 B

5、rief description of ventilation systems. More details should be given forcritical areas with potential risk of airborne contamination (schematic drawingof systems). Classification of the rooms used for the manufacture of sterileproducts should be mentioned;3.4 Special areas for the handling of the h

6、ighly toxic, hazardous and sensitizingmaterials;3.5Brief description of water system (schematic drawings of systems), includingsanitation; and3.6Description of planned preventive maintenance programs for premises and ofthe recording system.4 Equipment.4.1 Brief description of major equipment used in

7、 production and Quality ControlLaboratories (a list of equipment required);4.2 Description of planned preventive maintenance programs for equipment and of the recording system; and4.3 Qualification and calibration including the recording systems and arrangementsfor computerized systems validation.5

8、Sanitation. 5.1 Availability of written specifications and procedures for cleaning manufacturing areas and equipment.6 Documentation. 6.1 Arrangements for the preparation, revision and distribution of;6.2 Necessary documentation for the manufacture;6.3 Any other documentation related to product qual

9、ity that is not mentionedelsewhere (e.g. microbiological controls about air and water).7 Production.7.1 Brief description of production operations using, wherever possible, flow sheets and charts specifying important parameters;7.2 Arrangements for the handling of starting materials, packaging mater

10、ials, bulkand finished products, including sampling, quarantine, release and storage;7.3 Arrangements for the handling of rejected materials and products; and7.4 Brief description of general policy for process validation.8 Quality Control. 8.1 Description of the quality control system and of the act

11、ivities of the QualityControl Department. 9 Procedures for the release of the finished products.9.1 Loan licence manufacture and licensee.9.2 Description of the way in which compliance of Good Manufacturing Practicesby the loan licensee shall be assessed.10 Distribution, complaints and product recal

12、l. -10.1 arrangements and recording system for distribution; and10.2 arrangements for handling of complaints and product recalls.11 Self inspection. 11.1 short description of the self inspection system indicating whether an outside,independent and experienced external export was involved in evaluating the manufacturers compliance with Good manufacturing Practices in all aspects of production.12Export of drugs.12.1 products exported to different countries; and12.2 complaints and product recall, if any.