Source: Link Testing Instruments Co.,Ltd.
The "Good Manufacturing Practice for Pharmaceutical Packaging Materials" (hereinafter referred to as "Pharmaceutical Packaging Materials GMP"), officially implemented in 2025, systematically refines and expands upon the overall framework of the "Good Manufacturing Practice for Pharmaceuticals (2010 Revision)" (hereinafter referred to as "Pharmaceutical GMP"), specifically addressing the production characteristics and quality requirements of pharmaceutical packaging materials. This appendix not only comprehensively strengthens quality control throughout the entire production process of pharmaceutical packaging materials but also, for the first time, explicitly introduces several management and technical provisions specifically for pharmaceutical packaging materials. This marks a new chapter in Chinese pharmaceutical packaging materials regulation, characterized by greater scientific rigor and stricter standards. This article, based on the specific provisions of both regulations, systematically interprets the key new content of the Pharmaceutical Packaging Materials GMP and deeply analyzes its core differences and unique aspects compared to the Pharmaceutical GMP.
As a specific appendix to pharmaceutical GMP, pharmaceutical packaging materials GMP is essentially a concrete extension and specialized application of the core principles of pharmaceutical GMP in the field of pharmaceutical packaging materials production. While inheriting the basic spirit of pharmaceutical GMP, it makes targeted adjustments and additions based on the product characteristics of pharmaceutical packaging materials and their role in the pharmaceutical supply chain. By comparing the chapter structures of both, their corresponding relationships and main differences can be clearly seen.
Key differences mainly include:
Addition of a "Contract Management" chapter: This highlights the contractual relationship regarding quality responsibility between pharmaceutical packaging materials manufacturers and marketing authorization holders (MAHs), which is the most significant structural addition;
Integration of "Self-Inspection" and "Management Review": Self-inspection work is incorporated into a higher level of continuous improvement of the quality management system and combined with systematic management review;
Permission for "Contract Testing": Under the premise of establishing strict control procedures, it explicitly allows for the outsourcing of some testing items, reflecting the flexibility of management.
The GMP for pharmaceutical packaging materials puts forward more specific and actionable requirements for the quality management system, promoting the establishment of a measurable, traceable, and continuously improving management closed loop within enterprises.
Clarifying the dimensions of management review: Article 9 of the GMP for pharmaceutical packaging materials requires senior management to organize a management review at least once a year, and details the performance aspects to be evaluated, such as self-inspection, complaints, returns, and change deviation trend analysis, which is more specific than the GMP for pharmaceuticals.
Strengthening agreements and audits with MAHs: Articles 63, 71, and 73 mandate the signing of quality agreements with MAHs, clarifying the responsibilities of both parties and requiring acceptance of audits by the MAH. These are exclusive requirements not mandated in the GMP for pharmaceuticals.
Introducing quality performance evaluation: Through management review, the effectiveness of the quality system is quantitatively evaluated, promoting the visualization of quality management. This is also a management concept not explicitly stated in the GMP for pharmaceuticals.
The GMP for pharmaceutical packaging materials demonstrates stronger standardization and traceability in materials and supplier management.
Mandatory signing of quality agreements: Article 63 requires the signing of quality agreements with major material suppliers, while the GMP for pharmaceuticals only requires evaluation and auditing, without mandating written agreements.
Clarifying "re-testing period" management: Article 75 details the setting, triggering conditions, and operational requirements for the re-testing period of materials, addressing the lack of operational guidance in this area in the GMP for pharmaceuticals.
Detailed return traceability management: Article 69 stipulates that returns of the same batch number from different channels must be recorded and processed separately, strengthening the traceability control of return sources, which is more refined than the GMP for pharmaceuticals.
For the production process of pharmaceutical packaging materials, the GMP for pharmaceutical packaging materials establishes many exclusive clauses not covered in the GMP for pharmaceuticals.
Detailed management of molds: Article 22 proposes detailed procedures for the numbering, status, maintenance, and disposal of production molds, requiring far more than the general principles of the GMP for pharmaceuticals.
Graded requirements for cleaning water: Article 23 clarifies the quality standards of the final cleaning water (water for injection/purified water) based on the use of pharmaceutical packaging materials (sterile/non-sterile), filling a gap in the GMP for pharmaceuticals. Prohibition of reprocessing and restrictions on rework: Article 32 explicitly stipulates that intermediate products and finished products of pharmaceutical packaging materials shall not be reprocessed, and rework must be carried out under strict control, which is more stringent than the requirements for pharmaceutical preparations in the pharmaceutical GMP.
Regular re-validation of sterilization validation: Article 48 requires sterilization equipment to be re-validated at least once a year, clearly defining the validation frequency, which is not specifically stipulated in the main text of the pharmaceutical GMP.
The pharmaceutical packaging materials GMP proposes more detailed technical indicators in terms of environmental control.
Refined pressure difference gradient in clean areas: Article 18 not only requires a pressure difference of ≥10 Pa between different levels of clean areas, but also proposes that an appropriate pressure difference should be maintained between different areas of the same clean level when necessary, enhancing operability and environmental protection, which is more specific than the requirements of the pharmaceutical GMP.
The pharmaceutical packaging materials GMP emphasizes timeliness and system response capabilities in the management of the end of the product life cycle.
Standardization of electronic records and signatures: Article 39 clarifies the legality and management requirements of electronic records and electronic signatures, including review, authorized modification and record retention, which is more detailed than the provisions of the pharmaceutical GMP.
Emphasis on the immediacy of the recall system: Article 70 requires the recall system to be "activated at any time and implemented quickly," highlighting the timeliness requirements for emergency response, which is not explicitly emphasized in the recall clauses of the pharmaceutical GMP.
Establishment of a change classification management and notification mechanism: Article 64 requires enterprises to classify changes based on their impact on the key attributes of pharmaceutical packaging materials (protection, compatibility, etc.), and to notify relevant users, reflecting stronger collaboration and transparency.
The pharmaceutical packaging materials GMP establishes protection, compatibility, safety, and functionality as core quality attributes, and sets corresponding assessment and verification requirements.
Systematic integration of the four attributes: The four attributes are repeatedly emphasized throughout the text and required to be implemented throughout the life cycle, elevating them to the status of core quality objectives, while the requirements for packaging materials in the pharmaceutical GMP are relatively general.
Requirement for self-stability testing: Article 62 requires pharmaceutical packaging materials enterprises to conduct stability studies based on material characteristics and assess their impact during changes, which is a unique requirement for packaging materials. Clearly defined compatibility study requirements: The detailed regulations require compatibility verification through migration tests and adsorption studies, which is more in-depth and specific than the drug GMP's requirement that packaging materials merely "meet standards."
The pharmaceutical packaging materials GMP enhances the applicability of the regulations through clear terminology and differentiated requirements.
Clearly defined key terms: Article 75 clearly defines terms such as "packaging system" and "secondary packaging components," and indicates that their quality management can refer to this appendix, providing clear guidance on the scope of regulation.
Reflecting system flexibility: Article 74 allows pharmaceutical manufacturers to supplement their existing drug GMP system with additional clauses for self-produced and self-used pharmaceutical packaging materials, without the need to establish a separate independent system, making it more practical.
Differentiated personnel qualification requirements: The requirements for the educational qualifications and practical experience of production and quality managers (junior college degree or intermediate professional title, 2 years/3 years of experience) are lower than those in the drug GMP (bachelor's degree, 3 years/5 years of experience), which is more in line with the actual situation of the pharmaceutical packaging materials industry.
The implementation of GMP for pharmaceutical packaging materials is a crucial step in the standardization and refinement of quality management for pharmaceutical packaging materials in China. It sets forth more specific, stringent, and targeted requirements than drug GMP in areas such as quality management systems, material and supplier control, production processes, plant facilities, product traceability, and the management of unique properties of pharmaceutical packaging materials. This reflects a deepening of control over the entire production chain of pharmaceutical packaging materials and a strong emphasis on the collaborative assurance system between pharmaceutical packaging materials and pharmaceuticals.
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