On June 2, China National Medical Products Administration (NMPA) released the draft of Good Manufacturing Practice for Pharmaceutical Packaging Materials (hereafter referred to as Packaging GMP) for public comments.
The Packaging GMP specifies basic requirements for the manufacture management and quality control of pharmaceutical packaging materials.
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.1
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.
3.2. Management of Records
The manufacturer should keep all the records of manufacturing, control, verification, delivery & transport, sales, investigation for at least five years or a certain period after consultation with drug product manufacturers.
3.3. Management of Changes
Common changes during the manufacturing process include:
Changes to the manufacturing site, such as location change, reconstruction, expansion, transfer of the manufacturing technology, and manufacturing entrustment;
Changes to the ingredients and formulation;
Changes to the manufacturing techniques and process control;
Changes to the quality standards;
Changes to the product packaging;
Other changes that may affect the quality and expected use of pharmaceutical packaging materials.
Manufacturers should
establish standard procedures for controlling the changes;
make requirements for reporting, recording, investigating, and handling the changes;
keep the records of the changes;
study, evaluate, and manage the changes.
3.4. Entrustment of Manufacturing & Testing
For manufacturing entrustment, the entrusting and the entrusted parties should sign written contracts that specify each party's responsibilities, entrusted items, and relevant technical items. The entrusted party should comply with the GMP's manufacturing quality requirements.
For testing entrustment, the manufacturer should establish a management system for entrusted testing and outsourcing services to control relevant risks that may affect product quality.
4. GMP for Pharma Industry
Apart from for pharmaceutical packaging materials, GMP compliance is also required for active pharmaceutical ingredients (API), excipients, and finished dosage forms (FDF).
Product | GMP | Status |
API | In force (revised in 2010, effective from 2011) | |
Excipient | In force (effective from 2006) | |
2017 GMP/GDP Certification Standards for Pharmaceutical Excipient Suppliers | Not mandatory | |
Not mandatory | ||
Packaging Material | Good Manufacturing Practice for Pharmaceutical Packaging Materials (Consultation Draft) | Draft |
FDF | Good Manufacturing Practice for Pharmaceuticals | In force (revised in 2010, effective from 2011) |
5. Contact BaiPharm
For GMP compliance services, please contact BaiPharm. We offer
GMP compliance consultancy to meet current China (NMPA), European (EMA) and US (FDA) requirements;
Onsite GMP consultants to design and implement GMP-compliant processes and systems;
GMP facility design reviews;
Designing and conducting qualification & validation tasks;
GMP compliance pre-audits;
Vendor assurance/supplier audits.