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ICH Q7 API cGMP Questionnaire Audit （我Q7 API cGMP问卷调查审计）
API cGMP Facility Questionnaire Audit Checklist
TABLE OF CONTENTS
1. Objective 5
2. General Company Information 5
2.1. Name, Address, and Contact Information 5
2.2. Regulatory Inspections History 6
2.3. Manufacturing Processes 6
2.4. Responsible Persons 6
2.5. Company Overview 7
2.6. Manufacturing Information 7
3. Quality Management 8
3.1. Principles 8
3.2. Responsibilities of the Quality Unit(s) 9
3.3. Responsibility for Production Activities 10
3.4. Internal Audits (Self Inspection) 10
3.5. Product Quality Review 11
4. Personnel 11
4.1. Personnel Qualifications 11
4.2. Personnel Hygiene 12
4.3. Consultants 12
5. Buildings And Facilities 13
5.1. Design and Construction 13
5.2. Utilities 14
5.3. Water 15
5.4. Containment 15
5.5. Lighting 16
5.6. Sewage and Refuse 16
5.7. Sanitation and Maintenance 16
6. Process Equipment 17
6.1. Design and Construction 17
6.2. Equipment Maintenance and Cleaning 18
6.3. Calibration 19
6.4. Computerized Systems 19
7. Documentation and Records 20
7.1. Documentation System and Specifications 20
7.2. Equipment Cleaning and Use Record 21
7.3. Records of Raw Materials, Intermediates, API Labelling and Packaging Materials 22
7.4. Master Production Instructions (Master Production and Control Records) 23
7.5. Batch Production Records (Batch Production and Control Records) 24
7.6. Laboratory Control Records 25
7.7. Batch Production Record Review 25
8. Materials Management 26
8.1. General Controls 26
8.2. Receipt and Quarantine 27
8.3. Sampling and Testing of Incoming Production Materials 28
8.4. Storage 29
8.5. Re-evaluation 29
9. Production and In-Process Controls 30
9.1. Production Operations 30
9.2. Time Limits 31
9.3. In-process Sampling and Controls 31
9.4. Blending Batches of Intermediates or APIs 32
9.5. Contamination Control 34
10. Packaging and Identification Labelling of APIs and Intermediates 34
10.1. General 34
10.2. Packaging Materials 35
10.3. Label Issuance and Control 35
10.4. Packaging and Labelling Operations 36
11. Storag
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