The Technical Guide to The Study of Change of Pharmaceutical Package shipping materials has implemented the interpretation of regulatory difficulties and implementation key points.

On May 29, 2020, the official website of the China Pharmaceutical Packaging Association issued the Technical Guide for Research on Change sedative ssuppliey (T/CNPPA 3009-2020), which will be implemented from May 29, 2020, the date of publication, which is the first technical guide for research on change s/the pharmaceutical packaging materials in China, in line with the drug registration management measures and related regulations.
this article for you to sort out the drug package material supervision difficulties and implementation of key points, can be used for pharmaceutical package materials to provide change research of basic research ideas and basic evaluation principles, but also for pharmaceutical companies to carry out drug package change evaluation to provide reference.
. 1. Domestic drug package material regulatory model Pharmaceutical package products refers to the use of the same or similar production processes and materials, with the same or similar functions of products, including different models and specifications, is an indispensable part of the drug, it is accompanied by the production, circulation and use of drugs throughout the process, so the pharmaceutical package material selling to ensure the safety and effectiveness of drugs play an important role.
in recent years, with China's drug reform, the corresponding regulatory model of pharmaceutical packaging materials is also undergoing great changes, China's drug package material supervision model is from scratch, constantly improve, step by step process, from the drug packaging without any restrictions to the implementation of the production enterprise licensing system, to the pharmaceutical package "registration management system", the current reform is "associated review and approval system."
"registration management system" emphasizes "independent declaration, separate review and approval", while "associated review and approval system" emphasizes "re-reporting, associated review and approval".
other than that, the nature of the two is basically the same, i.e. both require technical review and approval. A
comparison can be found in the table below.
Table 1 Compared table II between the original registration management system of China's pharmaceutical package materials and the related review and approval system, the difficulties of domestic drug package material change management In the drug package material association review and approval system, the drug listing license holder is the first responsible person for product quality, but this does not mean that the responsibility of the pharmaceutical package production enterprise is lighter, in cooperation with the drug listing license holder research, improve product quality, the role of the pharmaceutical package production enterprise selling enterprises should not be left out of place.
associated review and approval system to drug market licensing holders and pharmaceutical package manufacturers to provide cooperation and technical exchange opportunities to better ensure the quality of drugs and drug safety, in the process, the package material enterprises are also responsible for the preparation enterprises, control the change of the drug package materials, and the preparation enterprises to take scientific assessment measures to avoid the change of the drug package materials to the drug Bring about adverse effects, China's current pharmaceutical package materials small and scattered, insufficient quality awareness, the capacity of all parts of the package enterprises are not the same, and there are also scale deviations in local supervision, therefore, the national drug regulatory departments need to introduce a joint review system related to the supporting technical guidance documents, such as the introduction of the "pharmaceutical package materials change research technical guide."
three, the key point of the implementation of the change of the drug package material 1, how to classify the change of the package material? For changes to pharmaceutical packages, the Guide classifies changes into technical and non-technical changes.
(1) Non-technical changes are mainly changes in the registration information of pharmaceutical package materials, the specific items are as follows: (2) technical changes, mainly changes in production address, prescription process, quality standards, etc., the specific items are as follows: This article for technical change projects in accordance with the high-risk package and non-high-risk package materials should be carried out in the study of what changes, marking red represents high-risk package materials, generally including Drug packmaterials for inhalation preparations, injections, eye preparations; new materials, new structures, new uses of pharmaceutical packages, pharmaceutical packages regulated by the State Administration of Food and Drug Administration in accordance with the special requirements of monitoring data; labeled green as non-high-risk pharmaceutical packages; and the number of research projects after the change of research content is counted (the number of research projects required by the representative; - representatives are exempt from research; and the study is assessed on a case-by-case basis).
2, what changes should be carried out in the change of production site?3. What changes should be carried out on raw materials and formulations?4. What changes should be studied for changes in production processes and process control?5. What changes should be carried out in the study of quality standardchanges?6, product packaging changes should carry out what changes to carry out research?7. What changes should be carried out in other technical types?Ref: s1