T/CPAPE 01-2024 Clean Contamination Control Strategy (CCS) Technical Guidelines for Pharmaceutical Manufacturing Processes

Scope

Scope: This guideline, based on the actual situation in China, aims to provide the industry with guidance on the design, implementation, evaluation, and management of pollution control strategies in the drug production process, under the premise of promoting compliance. It helps enterprises, institutions, and personnel in the industry understand the concept of pollution control strategies and more effectively establish and implement such strategies to achieve best practices. This guideline applies to microbial, pyrogen/endotoxin, and particulate contamination control practices in sterile drugs, and does not address requirements related to cross-contamination. It provides technical reference for pharmaceutical production and R&D enterprises, facility design units, and equipment manufacturers. Non-sterile drugs are not discussed in this guideline, but their pollution control improvements can be referenced when necessary. Main Technical Content: - Preface 1. General Provisions 1.1 Purpose 1.2 Scope 2. Normative Reference Documents 3. Terms and Abbreviations 3.1 Terms 3.2 Abbreviations 4. Fundamentals of Pollution Control Strategies 4.1 Scientific Knowledge 4.1.1 Production System Knowledge 4.1.2 Product and Process Knowledge 4.1.3 Microbial, Pyrogen/Endotoxin, and Particulate Knowledge 4.2 Concept of Quality Risk Management 4.3 Continuous Improvement Quality Management System 4.4 Quality Culture and Personnel Awareness 5. Application of Quality Systems in Pollution Control Strategies 5.1 Risk Management 5.2 Change Control 5.3 Investigation 5.4 Corrective and Preventive Actions (CAPA) 5.5 Quality Review and Trend Analysis 5.6 Supplier Management 5.7 Quality Control 6. Development of Pollution Control Strategies 7. Control Elements of Pollution Control Strategies 7.1 Facilities 7.1.1 Design of Facilities 7.1.2 Use, Maintenance, and Repair of Facilities 7.1.3 Daily Monitoring of Facilities 7.1.4 Periodic Review of Facilities 7.2 Equipment 7.2.1 Design of Equipment 7.2.2

Development Information

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