Strengthening Supervision and Management of Pharmaceutical Packaging Materials Hinges on Implementation

The current state of pharmaceutical packaging materials in China

At present, China's pharmaceutical packaging materials still face problems such as unsound production and quality management organizations within companies, unsound production quality management systems, hardware facilities at pharmaceutical packaging material companies that do not match their production scale, and testing capabilities at pharmaceutical packaging material companies that fall short of regulatory requirements.

Important causes include pharmaceutical packaging material companies' long-standing neglect of investment in software, a fairly serious tendency for departments within companies to act each on their own, testing capabilities that do not suit quality management, and weak technical supervision capacity at drug regulatory authorities.

Manufacturers must correctly understand the importance of pharmaceutical packaging materials and pay attention to quality supervision of them. Relevant departments should improve regulations on the supervision of pharmaceutical packaging materials and standardize production practices. Research on the pharmaceutical packaging material industry should be strengthened to make supervision work more targeted. A sound mechanism for quality supervision and sampling inspection of pharmaceutical packaging materials should be established and improved to strengthen technical oversight of products. Production and use practices should be standardized and brought into a law-based regulatory process.

Plans to implement the DMMF management system

The DMMF management system is a system implemented in developed countries for active pharmaceutical ingredients and excipients, packaging materials and chemical intermediates. Recently, Zhang Wei, director of the Drug Registration Department of the State Food and Drug Administration, said that there are plans to implement the DMMF management system.

At present, China applies an approval system to active pharmaceutical ingredients and packaging materials, whereas abroad a dossier management system is more common. Under the dossier management system, manufacturers of pharmaceutical packaging materials, excipients and raw materials establish dossiers and provide the relevant information to formulation companies, and the government conducts registration review through the dossiers; while reviewing a formulation, the government needs only one DMMF number during the review of the active ingredients and excipients. These dossiers involve two parts: a public part and a non-public part. The non-public part is generally a company's core secret, and companies are unwilling to provide it to formulation makers when selling products, so this part of the dossier is required to be filed with the government.

China should actively explore establishing a DMMF system suited to its national conditions, extend the reach of supervision and management, strengthen formulation manufacturers' management of active pharmaceutical ingredients, excipients and packaging materials, and require formulation manufacturers to audit raw materials, excipients and the like.

Research launched on packaging materials in direct contact with drugs

Commissioned by the Drug Registration Department of the State Food and Drug Administration, the China Pharmaceutical Packaging Association has officially launched a research project on the current state of packaging materials and containers that come into direct contact with drugs. The project will last one year and ultimately produce a related research report, offering recommendations for government departments in formulating a pharmaceutical packaging material policy and regulation system suited to China's national conditions.

This research mainly investigates the basic situation of existing pharmaceutical packaging material and drug manufacturers and pharmaceutical packaging material testing institutions at all levels, and how regulatory authorities at all levels supervise their production, distribution and use; it compares the differences between domestic and foreign management systems, studies and explores the establishment of a scientific and reasonable regulatory system suited to China's national conditions, and sets near-term and long-term goals for pharmaceutical packaging supervision in China. This research is the first of its kind in the history of the pharmaceutical packaging industry and is foundational work concerning the long-term development of the industry.

——This article is reprinted from China Packaging Network (pack.cn), original link: http://news.pack.cn/show-362291.html