Packaging is the immediate packaging materials and containers, is an inseparable part of the drug, protects the drug quality and safety, an important role is convenient for transportation, storage, sales and use, it’s quality, directly affect the drug quality, related to public safety. But for a long time, there is a “heavy drug regulatory departments, light package” concept, to the understanding of the importance of packaging regulation as drugs, affect the packaging quality supervision, strengthen and improve the supervision work need packaging.
Establish and perfect the supervision system of drug packaging materials
One is the revision, improve the existing “immediate packaging materials and containers management approach”, the relevant regulations and technical requirements and “Chinese Pharmacopoeia” (2010 Edition), the new GMP adaptation; two is the establishment of drug packaging materials production enterprises production license and GMP certification system, improve the access threshold for drug packaging materials production, software and hardware conditions of production enterprises makes clear a regulation, from the source to guarantee the quality of pharmaceutical packaging; the three is the development and introduction of drug packaging materials production and use of supervision and management measures, clear at all levels of the drug administration department functions and responsibilities for the daily supervision, to provide legal security.
Guidance system packaging technology
According to the nature, different packaging products, quality standards and production process, according to “guidance” principle, the development and introduction of systematization, standardization technical guiding principle, to promote the development of science and technology for product development. At the same time, should also encourage innovation, support enterprises in research, production and use of new packaging, new packaging registration implements the special examination and approval system, to provide a full range of guidance services, speed up the progress of the approval.
Earnestly perform their duties of supervision
To do the administrative supervision and technical supervision of the two wheel drive. On the one hand, strengthen the production enterprise packaging daily supervision and inspection, establish inspection rules, clear inspection frequency, drug administration departments at all levels to establish effective communication and coordination mechanism, production enterprises focus on examination of packaging is in accordance with the product registration approval requirements of production, whether plant, workshop, equipment and personnel to meet the requirements. On the other hand, to strengthen the construction of ability of detecting drug inspection department, increase the funds, equipment and personnel input, strengthen business training and study, establish technical strength and adapt to the packaging of supervision, from the source to control product quality. In addition, we should strengthen the packaging quality supervision and inspection, improve packaging quality inspection system and the quality of pharmaceutical packaging announcement system, regularly publish packaging sampling results, give full play to the role of technical supervision.
Adding home network system advocacy and technical training
Take seminars, symposia, issuing brochures and other forms, to strengthen the “Drug Administration Law”, “Drug Administration Law”, “Regulations for the implementation of direct contact with the packaging materials and containers management approach” and other laws and regulations publicity and education, and guide enterprises to firmly establish the legal consciousness, responsibility consciousness, promote enterprise in accordance with the law, standardize engaged in production and business activities. In addition, regulators should focus on business training, and actively organize professional and technical training, explain in detail the production management, quality management, product testing and other aspects of knowledge, improve the quality of enterprise management and professional and technical level.