-
E-mail
changliu006@126.com
-
Phone
18915420690
-
Address
Room 402, Building 117, Shuangyin International, No. 1388 Dongfang Avenue, Wuzhong District, Suzhou
Suzhou Yikang Environmental Testing Co., Ltd
GMP verification of pharmaceutical packaging materials and interpretation of the latest regulations
Date: 2025-07-10Read: 6
GMP verification of pharmaceutical packaging materials and interpretation of the latest regulationsThe revised version of GMP packaging appendix in 2010 will be officially implemented from January 1, 2026,
In the current era where drug safety is highly valued, the quality and compliance of drug packaging materials, as the direct contact carrier of drugs, directly affect the safety and effectiveness of drugs. Recently, the National Medical Products Administration released the appendix of the "Good Manufacturing Practice for Drugs (Revised in 2010)" for pharmaceutical packaging materials, which will be officially implemented from January 1, 2026, pointing out a new direction for the GMP verification work of pharmaceutical packaging material production enterprises.
This appendix consists of 13 chapters and 75 articles, covering key areas such as quality management, organization and personnel, plant and facilities, equipment, materials and products, confirmation and verification, document management, etc. In the confirmation and verification process, it is explicitly required that enterprises fully verify their factories, facilities, equipment, and processes to ensure that they can continuously and stably produce pharmaceutical packaging materials that meet the intended use and registration requirements. For example, for sterile drug packaging materials, the final cleaning water must be injection water; For non sterile drug packaging materials, the cleaning water must at least meet the requirements of the Chinese Pharmacopoeia for purified water, which poses a higher standard for equipment cleaning validation.
From the perspective of risk management, regulations have specific requirements for the packaging of sterile supply drugs and drugs used for high-risk preparations. The clean area needs to be monitored according to the cleanliness level and monitoring requirements under the sterile drug appendix of the Good Manufacturing Practice for Drugs, and the impact of the environment on the quality of drug packaging materials should be strictly controlled. In terms of material management, enterprises should regularly evaluate the quality of the raw materials used in the production of pharmaceutical packaging materials, organize production according to the information registered on the original and auxiliary package registration platform of the National Medical Products Administration's Drug Evaluation Center, and strictly inspect each batch of products. Only after approval by the quality management department can they be released.
Provincial drug regulatory departments will also organize supervision and inspection of pharmaceutical packaging material production enterprises with a registration status of "A" (through technical evaluation) within the administrative region based on the information on the original auxiliary package registration platform of the drug review center, urging enterprises to strictly produce according to the registration information and conduct quality inspections if necessary. This means that companies must maintain a high level of compliance throughout the entire production cycle, and any negligence may face strict scrutiny from regulatory authorities.
Our GMP verification service for pharmaceutical packaging materials closely adheres to the latest regulatory requirements, providing you with a one-stop solution from policy interpretation to scheme development, from on-site verification to document organization, helping you easily cope with regulatory changes and ensure compliance throughout the entire production process of pharmaceutical packaging materials.
Suzhou Yikang Environmental Yikang Testing Co., LtdGMP verification service for pharmaceutical packaging materials, with professionalism as the pen and compliance as the ruler, builds a full process quality moat for your products from research and development to production.Full chain technical support, covering the entire verification cycle from DQ (design confirmation), IQ (installation confirmation), OQ (operation confirmation) to PQ (performance confirmation), and synchronously covering cleaning verification, process verification, and stability assessment.
Last Article: 2025 Revised GMP Requirements for Airflow Flow Pattern Testing
Next Article: GMP validation of raw materials and new regulations