China Consults on GMP for Pharmaceutical Packaging Materials

Jun. 14th, 2022
2112

On June 2, China National Medical Products Administration (NMPA) released the draft of Good Manufacturing Practice of Pharmaceutical Packaging Materials (hereafter referred to as Packaging GMP) for public comments.

The Packaging GMP specifies basic requirements for the manufacturing management and quality control of pharmaceutical packaging materials.

packaging

 

Contents


1. Application Scope of Packaging GMP

2. Contents of Packaging GMP

3. Packaging GMP Requirements

4. GMP for Pharma Industry

 

1. Application Scope of Packaging GMP


Pharmaceutical packaging materials refer to

  • Packaging materials and containers that have direct contact with pharmaceuticals;
  • Functional secondary packaging materials, surface printing materials, components, and drug delivery devices & systems.

The Packaging GMP applies to the overall manufacturing process of pharmaceutical packaging materials, including

  • all the critical factors that affect the packaging materials’ quality, and
  • all the organized and planned activities to ensure the packaging materials accord with the intended uses.

 

2. Contents of Packaging GMP


GMP for Pharmaceutical Packaging Materials (Consultation Draft)
Chapter 1 General Principles
Chapter 2 Quality Management Section 1: Principles
Section 2: Internal Review and Administrative Evaluation & Audit
Chapter 3 Institution and Personnel
Chapter 4 Factory and Facility
Chapter 5 Equipment
Chapter 6 Material and Product
Chapter 7 Verification and Validation
Chapter 8 Document Management Section 1: Principles
Section 2: Standard Procedures for Manufacturing
Section 3: Batch Manufacturing Record
Chapter 9 Manufacturing Management Section 1: Principles
Section 2: Manufacturing Process Control
Section 3: Clean Production and Pollution Control & Management
Section 4: Manufacture Labeling (for Containers, Equipment, and Facilities)
Section 5: Product Storage and Transport
Chapter 10 Quality Control and Quality Assurance
Chapter 11 Entrusted Manufacturing & Testing
Chapter 12 Product Delivery, Transport, and Recall
Chapter 13 User Management Service
Chapter 14 Glossary

 

3. Packaging GMP Requirements


3.1 Internal Audit and Administrative Evaluation

Every year, a pharmaceutical packaging material manufacturer should conduct at least one internal review and at least one administrative evaluation & audit for its quality management system (QMS).

To entrust the audit to an external party, the manufacturer should make standard procedures for the external GMP audit, specifying the qualification requirements, principles for selection, and the procedures for approving the auditor.

 

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