China Consults on GMP for Pharmaceutical Packaging Materials

by Grace Wang Jun 09, 2022

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 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

Good Manufacturing Practice for Pharmaceuticals

In force (revised in 2010, effective from 2011)

Excipient

Good Manufacturing Practice for Pharmaceutical Excipients

In force (effective from 2006)

2017 GMP/GDP Certification Standards for   Pharmaceutical Excipient Suppliers  

Not mandatory

SPPEA Excipient GMP Guidelines (Trial)

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.

Grace Wang
ChemLinked Regulatory Analyst
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