Domestic and foreign experts jointly discuss the standards for medicinal glass

With the approaching implementation of the review and approval system for the association between pharmaceutical packaging materials and excipients, the pharmaceutical glass industry, as a packaging material that directly contacts drugs, has received increasing social attention. Its quality standards and standardized use have once again attracted the attention of formulation and pharmaceutical glass enterprises.

The first conference of the series of related review and approval system seminars, the International Symposium on Medicinal Glass Standards, was held in Ruicheng, Shanxi from July 8th to 9th.

This seminar is guided by the National Pharmacopoeia Commission, hosted by the China Pharmaceutical Packaging Association, and hosted by Shanxi Hongguang Medical Glass Co., Ltd. More than 100 leaders from the State Food and Drug Administration (CFDA) and the National Pharmacopoeia Commission, experts from testing institutions, well-known pharmaceutical production enterprises, and pharmaceutical glass production enterprises attended the meeting. The meeting focused on the upcoming implementation of a related review system, and held in-depth discussions on important topics such as pharmaceutical packaging material standards, selection of biopharmaceutical packaging materials, compatibility research between drugs and pharmaceutical packaging materials, quality control of pharmaceutical glass, and technical requirements related to Sino US pharmaceutical glass.

Related review helps clarify responsibilities and reduce approvals

On May 12th, the State Food and Drug Administration issued a notice (draft for soliciting opinions) on matters related to the review and approval of the association between pharmaceutical packaging materials, excipients, and drugs, marking the gradual progress of the implementation of association review.

The implementation of the review and approval of the association between pharmaceutical excipients, pharmaceutical packaging materials, and formulations can be regarded as a major turning point and opportunity for the development of the pharmaceutical packaging material industry.

It is understood that the production technology and management level of pharmaceutical packaging materials in China are constantly improving, and the quality standard system is gradually improving. 130 national standards for pharmaceutical packaging materials have been issued, and 5166 registration certificates for pharmaceutical packaging materials have been issued. "The current approval system has played an important role in regulating and promoting industrial development. If that's the case, why should it be changed?" An official from the CFDA Drug and Chemical Registration Department pointed out that in the past, "nanny style supervision" was implemented on formulation enterprises, and the responsibility for quality problems was often unclear. The implementation of related party reviews is to make formulation enterprises bear the main responsibility for quality, and it is also conducive to highlighting the market subject position of formulation enterprises, It allocates upstream enterprise resources; Secondly, the separate approval of packaging materials and auxiliary materials wastes resources, and the reform is conducive to reducing administrative approval.

"After implementing the association review, relevant enterprises should focus on grasping the three principles of're reporting of use ',' risk management ', and' change handling ', starting the research of pharmaceutical packaging materials and excipients from drug research and development, starting from a higher starting point, and achieving a smooth policy transition." The CFDA officer emphasized above.

Hong Xiaoxu, Director of the Comprehensive Department of the National Pharmacopoeia Commission, stated that due to the potential safety risks of pharmaceutical packaging materials and excipients to drugs, the country and industry are very concerned about the quality of pharmaceutical packaging materials and have put forward higher requirements for them. With the advancement of quality and efficacy consistency evaluation of generic drugs, the construction of quality standard systems for pharmaceutical packaging materials and excipients is becoming increasingly important. Pharmaceutical packaging material enterprises should start from ensuring quality, break through technical barriers, strengthen cooperation with pharmaceutical enterprises, understand the needs of pharmaceutical enterprises, actively participate in the formulation of relevant standards, and continuously improve the quality and technical level of pharmaceutical packaging materials.

Cai Hong, Secretary General of the China Pharmaceutical Packaging Association, pointed out that pharmaceutical companies are the first responsible person for drug quality. The implementation of the drug packaging materials, pharmaceutical excipients, and drug related review and approval system aims to simplify the drug approval process and conduct scientifically reasonable audits of drugs and their packaging materials in accordance with risk management principles. After implementing the associated review, the applicant for the formulation is the first responsible/applicant, which will inevitably promote cooperation between the pharmaceutical factory and packaging material enterprises, and promote the survival of the fittest of pharmaceutical packaging material enterprises. For pharmaceutical companies, it is necessary to attach importance to and standardize the audit of pharmaceutical packaging materials and excipients, attach importance to the content and procedures of changes, comprehensively and deeply understand and master the standards, product performance, production management process, and other information of pharmaceutical packaging materials and excipients. By conducting strict and standardized supplier audits, we can ensure the quality of the used pharmaceutical packaging materials and excipients, and ultimately take responsibility for the quality of the drugs.

Sun Yi, Director of the Infusion Business Unit of Jiangsu Hengrui Pharmaceutical Co., Ltd., stated that packaging is an integral part of formulations, and drug evaluation is truly related to the packaging system. Therefore, the selection of drug packaging materials should start with drug research and development. Related review is a significant change in the national drug approval system. It is hoped that the implementation of this system will not only simplify the approval process and reduce the review process, but also play a role in promoting scientific and reasonable review, protecting resources, saving funds, and encouraging innovation.

Upgrading pharmaceutical packaging technology standards is urgent

In recent years, the impact of pharmaceutical packaging materials on drug quality has become increasingly prominent, especially the impact of glass packaging materials on injection quality, which has attracted high attention from the industry. With the upcoming related review as an endorsement, the technical standards, quality control, and compatibility research of pharmaceutical glass and other packaging materials have become a hot topic of discussion for many pharmaceutical companies and packaging material industry leaders.

It is understood that particle exceeding standards caused by glass packaging detachment of sodium bicarbonate injection have occurred repeatedly, and the United States is no exception. Xu Liangfeng, Quality Director of Yabao Pharmaceutical Group Co., Ltd., stated in a list of issues with the use of glass ampoules and penicillin bottles that there are erosion marks on the inner surface of the glass; If there are significant changes in the concentration of Si element, particle number, and pH value in the test solution, it indicates a higher possibility of glass container delamination.

Starting from the reform proposal of self association review, the China Pharmaceutical Packaging Association has increased its efforts to promote member enterprises to ensure product quality and cooperate with the development of formulations. Emphasize production process management and develop and implement quality management standards for pharmaceutical packaging materials production; Standardize supplier audits and develop supplier audit guidelines; Improve the standardization system construction of associations; Conduct research on the quality evaluation system for pharmaceutical packaging materials.

As an expert involved in the formulation of the 13th Five Year Plan for the development of the pharmaceutical industry, Cai Hong has a deep understanding of the status enhancement and related development of packaging in the pharmaceutical industry. She introduced that packaging and drug delivery systems will become a key development area for the pharmaceutical industry during the 13th Five Year Plan period. Specifically, it includes developing new materials with high safety and good quality performance, and gradually phasing out varieties with high quality and safety risks. Key efforts will be made to accelerate the transformation of injection packaging from low borosilicate glass bottles to neutral borosilicate glass bottles, and to develop new materials such as cycloolefin polymers and styrene based thermoplastic elastomers used in products such as syringes, infusion bags, and blood bags, as well as high barrier materials for easily hygroscopic and oxidizing drugs, to improve the quality level of pharmaceutical grade polypropylene, polyethylene, and halogenated butyl rubber. In addition, new packaging systems and drug delivery devices will be developed to provide specific functions that meet the technical requirements of the formulation, improve patient compliance, and ensure medication safety. The focus will be on developing specialized drug delivery devices for aerosols and powders, as well as new types of syringes such as self administered syringes, pre filled syringes, automatic mixing devices, multi chamber bags, and infusion packaging with the function of removing insoluble particles, with memory function Intelligent packaging system with quality monitoring function, child safety packaging for commonly used medicines in households, and elderly friendly packaging.

Text/Reporter Liu Zhimei from China Medical News/Image from the internet