Pharmaceutical Good Manufacturing Practice Regulations - Chapter - Laws & Regulations Database of The Republic of China (Taiwan)

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Chapter

Title：	Pharmaceutical Good Manufacturing Practice Regulations CH
Category：	Ministry of Health and Welfare（衛生福利部）

Part 1 General Provisions § 1

Part 2 Good Manufacturing Practices for Pharmaceuticals § 3

Chapter 1 Good Manufacturing Practices for Western Pharmaceuticals § 3

Chapter 2 Good Manufacturing Practices for Chinese Herbal Medicines § 4

Section 1 General Provisions § 4

Section 2 Environmental Sanitation § 7

Section 3 FactoryBuildings and Facilities § 8

Section 4 Facilities § 15

Section 5 Organization and Personnel § 22

Section 6 Management of Raw Materials and Product Containers and Caps § 26

Section 7 Manufacturing Process Control § 30

Section 8 Management of Packaging and Labeling § 36

Section 9 Storage, Shipping and Sales § 40

Section 10 Quality Control § 42

Section 11 Records and Reports § 45

Section 12 Handling of Complaints and Returned Products § 52

Section 13 Pharmaceuticals for Use in Clinical Trials § 54

Part 3 Good Manufacturing Practices for Medical Devices § 60

Chapter 1 General Provisions § 60

Chapter 2 Standard Mode § 63

Section 1 Quality Management System § 63

Section 2 Management Responsibility § 68

Section 3 Resource Management § 79

Section 4 Product Realization § 84

Section 5 Measurement, Analysis and Improvement § 113

Chapter 3 Essential Mode § 124

Chapter 4 Medical Devices for Use in Clinical Trials § 140

Part 4 Supplementary Provisions § 146