A China Good Manufacturing Practices (GMP) on Pharmaceutical Packaging has been drafted and released for comments by industry stakeholders.
The "Quality Management Specification for Pharmaceutical Packaging Materials Production" has been developed to guide pharmaceutical packaging material manufacturers to standardize their production. It also guides pharmaceutical marketing license holders in performing their duties when reviewing pharmaceutical packaging material suppliers.
The China Good Manufacturing Practices for Pharmaceutical Packaging will assist the implementation of the Drug Administration Law (December 2019) and the Measures for the Supervision and Administration of Drug Production (July 2020).
Comments can be submitted up until July 2, 2022 – see below for further information.
Highlights of the China GMP Pharmaceutical Packaging
Chapter I General Provisions
- The pharmaceutical packaging materials in this GMP mainly refer to packaging materials and containers that are in direct contact with drugs. The GMP also includes functional secondary packaging materials, surface printing materials, components and drug delivery devices.
- This GMP applies to the entire production process of pharmaceutical packaging materials, which are similar to drug requirements.
- The purpose is to minimize the risk of contamination, cross-contamination, mix-ups and errors during the production of pharmaceutical packaging materials, and to ensure a continuous and stable supply of pharmaceutical packaging materials that meet pharmaceutical requirements and intended uses.
- Manufacturers shall truthfully record the information of the production quality management process to ensure that the information is true, accurate, complete and traceable.
Chapter II Quality Management
- The senior management should ensure that the established quality objectives are achieved, and that personnel at different levels and suppliers should participate in achieving these objectives and assume their own responsibilities accordingly
- Manufacturers shall conduct internal audits at least once a year to assess whether their quality management systems meet the requirements of this practice.
Chapter III Institutions and Personnel
- Manufacturers should set up independent Quality Management departments to perform the duties of quality assurance and quality control. The Quality Management department shall be involved in all quality-related activities and shall be responsible for reviewing all documents related to this specification.
- The personnel of the Quality Management department shall not delegate their responsibilities to the personnel of other departments.
- The key personnel shall be full-time personnel employed by the manufacturer. As a minimum the following positions must be held by full-time staff:
- CEO / General manager or equivalent
- Production Manager or equivalent
- Quality Manager or equivalent
- The Quality Manager and the Production Manager shall not serve concurrently.
- Manufacturers should formulate and implement training procedures, and all personnel related to the production and quality of pharmaceutical packaging materials should be trained.
- Manufacturers should manage personnel health including establishing personnel health records.
Chapter VI Materials and Products
- The raw materials used in the production of pharmaceutical packaging materials shall meet the corresponding quality standards.
- Manufacturers should formulate management procedures for the receipt, storage, distribution, use and delivery of materials and products used in the production of pharmaceutical packaging materials.
- The flow of materials and products used in the production of drug packaging materials can be traced.
Chapter VIII File management
- Each pharmaceutical packaging material should have production process SOPs approved by the enterprise.
- The production process specification shall not be changed arbitrarily. If changes are needed, they should be revised, reviewed and approved in accordance with the relevant operating procedures.
- Each batch of products shall have corresponding batch production records, which can trace the production history of the batch of products and the conditions related to the quality of the batch of products.
- The original blank batch production records shall be reviewed and approved by the Production Manager and the Quality Manager.
Chapter IX Production Management
- The site should be cleared after each production to ensure that no materials, products and documents related to this production are left behind in the equipment and workplace. Before the next production starts, the last clearance should be confirmed.
- Manufacturers should formulate operating procedures for dividing product production batches, and the division of production batches should be based on the principle of ensuring product traceability and quality uniformity. A general production batch is a batch of products that are continuously produced within a certain period of time using the same formula, the same process, and the same specification.
Chapter X Quality Control and Quality Assurance
- The quality control laboratory shall develop relevant documents including quality standards, sampling procedures and inspection procedures as minimum requirements.
- All products shall be released after being reviewed and approved by the quality management department, and substandard products shall not be released from the factory.
- The quality control laboratory shall establish operating procedures for the investigation of test results exceeding the standard. Any test results exceeding the standard must be fully investigated and documented in accordance with the operating procedures.
- The retained samples should generally be kept for five years, or the time limit for storage should be determined through consultation with the drug manufacturer, and the amount of retained samples should at least meet the needs of identification.
- The stability investigation of pharmaceutical packaging materials should be documented and recorded.
How to submit comments on the China GMP Drug Packaging
The deadline for comments is July 2, 2022. Comments may be sent directly to ypjgs@nmpa.gov.cn. The subject of the email should be marked as "Feedback on the production quality management standards for pharmaceutical packaging materials ".
Victoria Caldy
Business Development & Marketing Director
Cisema
victoria.caldy@cisema.com
cisema.com
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Victoria Caldy
Business Development & Marketing Director
Cisema
victoria.caldy@cisema.comcisema.com
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