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Laws & Regulations

PIC/S GUIDE TO GOOD DISTRIBUTION PRACTICE FOR MEDICINAL PRODUCTS 【Date:2016-05-16】 unit:風險管理組

DOCUMENT HISTORY
INTRODUCTION
PURPOSE
SCOPE
CHAPTER 1 QUALITY MANAGEMENT
1.1 PRINCIPLE
1.2 QUALITY SYSTEM
1.3 MANAGEMENT OF OUTSOURCED ACTIVITIES
1.4 MANAGEMENT REVIEW AND MONITORING
1.5 QUALITY RISK MANAGEMENT
 
CHAPTER 2 PERSONNEL 
2.1 PRINCIPLE
2.2 GENERAL
2.3 DESIGNATION OF RESPONSIBILITIES 
2.4 TRAINING
2.5 HYGIENE 
 
CHAPTER 3 PREMISES AND EQUIPMENT
3.1 PRINCIPLE
3.2 PREMISES 
3.3 TEMPERATURE AND ENVIRONMENT CONTROL
3.4 EQUIPMENT
3.5 COMPUTERISED SYSTEMS 
3.6 QUALIFICATION AND VALIDATION
 
CHAPTER 4 DOCUMENTATION 
4.1 PRINCIPLE 
4.2 GENERAL
 
CHAPTER 5 OPERATIONS
5.1 PRINCIPLE
5.2 QUALIFICATION OF SUPPLIERS 
5.3 QUALIFICATION OF CUSTOMERS
5.4 RECEIPT OF MEDICINAL PRODUCTS 
5.5 STORAGE 
5.6 DESTRUCTION OF OBSOLETE GOODS
5.7 PICKING
5.8 SUPPLY
5.9 IMPORT AND EXPORT 
 
CHAPTER 6 COMPLAINTS, RETURNS, SUSPECTED FALSIFIED MEDICINAL PRODUCTS AND MEDICINAL PRODUCT RECALLS
6.1 PRINCIPLE
6.2 COMPLAINTS
6.3 RETURNED MEDICINAL PRODUCTS 
6.4 FALSIFIED MEDICINAL PRODUCTS
6.5 MEDICINAL PRODUCT RECALLS
 
CHAPTER 7 OUTSOURCED ACTIVITIES
7.1 PRINCIPLE 
7.2 CONTRACT GIVER
7.3 CONTRACT ACCEPTOR
 
CHAPTER 8 SELF-INSPECTIONS
8.1 PRINCIPLE 
8.2 SELF-INSPECTIONS
 
CHAPTER 9 TRANSPORTATION
9.1 PRINCIPLE
9.2 TRANSPORTATION 
9.3 CONTAINERS, PACKAGING AND LABELLING 
9.4 PRODUCTS REQUIRING CONTROLLED CONDITIONS
 
ANNEX 1