Implementation of the “Measures for the Administration of Materials and Containers for Pharmaceutical Packaging” for the common people to use drugs plus an insurance

Responsible person of the China Pharmaceutical Packaging Association on the implementation of the "Measures for the Administration of Pharmaceutical Packaging Materials and Containers (Interim)" On April 29, 2000, the State Drug Administration issued the "Pharmaceutical Packaging Materials and Containers Management" in accordance with Decree No. 21. Measures (tentative) (hereinafter referred to as "Measures") shall be implemented on October 1 of the same year. Under what circumstances was the "Measures" issued? What are its main contents? What preparations should the company make before implementing the measures? How to register? A few days ago, the reporter interviewed the relevant person in charge of the China Pharmaceutical Packaging Association on many issues related to the implementation of the Measures.
Question: The issuance of the "Measures" is undoubtedly a major measure to strengthen the strict management of pharmaceutical packaging materials. Please talk about why we must strengthen the strict management of pharmaceutical packaging materials.
A: Because the medicine is a special commodity, its packaging requirements are very strict. It not only requires that the packaging meets the GM P specifications (direct contact with pharmaceutical packaging) during production and distribution, but also has special requirements for the stability of its chemical and physical properties. Therefore, we must strengthen the strict management of pharmaceutical packaging materials and containers.
Since the reform and opening up, the production of pharmaceutical packaging materials in China has developed rapidly and has formed a pivotal industry. But with it, there are structural contradictions. Most of the companies are small in scale. Most of the products have poor quality and low grades, resulting in 65% of the products failing to reach the international level in the 1980s. This will not only result in disorderly competition and market chaos, but also have a direct impact on the quality of medicines. If it is not rigorously governed by law, it will certainly hinder the healthy development of the pharmaceutical economy.
China's imminent accession to the WTO will make China's pharmaceutical packaging companies face a severe test. The development of the situation requires that our enterprises should be in line with international standards as soon as possible, start with development strategies, change operational mechanisms, adjust product structure, increase investment in science and technology, and improve product quality and innovation capabilities. At the same time, the external environment must also be guaranteed and strictly managed.
Question: In what historical context did the "Measures" come into being?
Answer: In order to ensure the quality of medicines, improve the pharmaceutical packaging technology, and purify the packaging market, for many years, the State Administration of Medicine has issued a series of laws and regulations to gradually bring China's pharmaceutical packaging industry onto the track of standardization and legalization.
On January 13, 1981, the State Administration of Pharmaceutical Administration issued the “Drug Packaging Management Regulations” (trial), which is the beginning of the legal industry in the pharmaceutical packaging industry.
After 6 years of implementation of the Pharmaceutical Packaging Management Regulations (Trial Implementation), the State Administration of Pharmacy has implemented trials on the “measures” and the development of domestic packaging technology, materials, and machinery, with reference to the statutes, regulations and guidelines for pharmaceutical packaging in advanced countries. The "approach" is revised. The revised "Drug Packaging Management Regulations" was issued in February 1988 and implemented on September 1 of the same year.
On May 28, 1991, the State Administration of Pharmacy issued the Decree No. 10 “Measures for the Administration of the Production of Pharmaceutical Packaging Materials and Containers (Trial)”, with a focus on the implementation of a licensing system for packaging materials and container companies that produce direct contact with pharmaceuticals.
On April 29, 1996, the State Administration of Pharmacy issued the Decree No. 15 “Quality Control Practices for Packaging Materials and Containers Directly in Contact with Drugs” (Trial). The professional committees of the China Pharmaceutical Packaging Association drafted the implementation rules for different product manufacturers according to the relevant provisions of Decree No.15.
The introduction of the above-mentioned regulations has indeed played a positive role in regulating the order of production and operation of pharmaceutical packaging materials and containers and improving product quality. However, due to the institutional problems at that time, there were many politicians and many loopholes in management, which made it difficult to implement laws and regulations smoothly.
On June 14, 1998, state organs carried out organizational reforms and set up the State Drug Administration. On the basis of summarizing the laws and regulations that had been issued and the implementation status, on April 29, 2000, Decree No. 21, “Measures for the Administration of Pharmaceutical Packaging Materials and Containers (Interim)” was issued, and the classification of pharmaceutical packaging materials and containers was started. The Registration System for Pharmaceutical Packaging Materials Registration Certificate has moved from a unified supervision and management track.
Q: What are the main contents of the Measures?
Answer: The scope of supervision of the "Measures" includes all-round management of the production, operation and use of pharmaceutical packaging materials. The specific manifestation of the "Regulations" clearly regulated is the implementation of a product registration system for drug packaging materials by the state. The embodiment is the issuance of the Certificate of Registration for Pharmaceutical Packaging Materials, and will no longer issue a "License of Pharmaceutical Packaging Manufacturers" in the future. Unregistered pharmaceutical packaging materials must not be manufactured, sold, operated and used.
The Measures stipulates that product registration is divided into three categories: Category I refers to materials and containers for pharmaceutical packaging that are directly in contact with drugs and used directly; Category II refers to materials and containers that are directly exposed to drugs, but are easy to clean, can be sterilized and sterilized Category III refers to the packaging materials and containers for pharmaceutical products that may directly affect the quality of drugs.
The "Measures" stipulates that product standards are divided into three levels: state, industry and enterprise. Where national and industrial standards are formulated and revised by the State Food and Drug Administration, but not yet included, enterprises that apply for product registration shall establish enterprise standards.
The "Measures" determined that the registration of drug packaging materials should be managed in accordance with the principle of "unified management, hierarchical responsibility". Type I and imported drug packaging products are approved by the State Food and Drug Administration for registration; Type II and III drug packaging products are registered by the provincial, district and municipal food and drug administration bureaus, and are filed with the State Food and Drug Administration and sent to the “Pharmaceutical Package”. Wood Registration Certificate." The Certificate of Registration of Pharmaceutical Packaging Materials and the Registration Certificate of Imported Pharmaceutical Packaging Materials are printed uniformly by the State Food and Drug Administration. The Certificate of Registration for Pharmaceutical Packaging Materials is valid for 5 years, and the Certificate of Registration for Imported Pharmaceutical Packaging Materials is valid for 3 years. The expiration of the application period is subject to the renewal of the first six months.
The "Measures" determine that in addition to registration to comply with relevant product standards, but also in line with national and departmental legal provisions and policies and regulations, in particular, to meet the relevant product quality assurance system.
The Measures also provide for penalties. Any violation of this measure shall be punished with a warning and a fine of up to 30,000 yuan.
Q: When was the "Measures" formally implemented? What time must the old enterprise producing different drug packaging products complete this work?
A: The “Measures” provisions are implemented starting from October 1, 2000, which is a new addition to the production of pharmaceutical packaging materials by newly-started pharmaceutical packaging companies or original pharmaceutical packaging companies. All types of I, II, and III pharmaceutical packaging products must be registered in accordance with the procedures provided for in the Measures. After being approved by the audit, they can be produced and sold only after being issued to the Certificate of Registration for Pharmaceutical Packaging Materials.
The enterprises that originally obtained the License for Pharmaceutical Packaging Materials Production Enterprises shall apply for the reissuance of the "Paper Pack Material Registration Certificate" within the relevant time limit within the scope of approved production of pharmaceutical packaging materials. There are four types of pharmaceutical butyl rubber stoppers, plastic infusion bottles (bags), pharmaceutical polyvinyl chloride (PVC) rigid films, and pharmaceutical packaging (PTP) aluminum foils in category I products, which were stipulated in March 2001. Recently submitted an application and completed the preliminary review, reported to the State Food and Drug Administration for approval; the remaining Class I drug packaging materials, the provisions of the application by the end of 2001 and completed the preliminary review, reported to the State Food and Drug Administration approval. The renewal of Type II and Type III drug packaging materials shall be completed before the end of 2002, and shall be specifically arranged by the provincial, municipal, and district Food and Drug Administration.
If, before the specified time limit, the original production time has been approved, it must be promptly applied for replacement. For products that have been discontinued for some reason and cannot be replaced as scheduled, their application rights can be retained until June 30, 2003.
Q: According to this "Measure", which products will no longer be registered in the future? Which products must be eliminated at the specified time?
Answer: Products that are not allowed to be manufactured and used are not allowed to be produced, sold, and used, such as non-foldable ampoules, copper-tin ointment tubes, cork stoppers, and ampoules for powder injections (including freeze-dried powder injections). Strictly investigate.
Due to the impure composition of natural rubber stoppers, aging, shielding, and poor sealing performance, the “Measures” stipulates that they must be strictly managed. In the future, registration of new start-up companies and workshops will no longer be carried out, and the originally approved production capacity will not be expanded. From the end of 2004, no pharmaceutical preparations are allowed to use natural rubber stoppers.
The use of natural rubber stoppers is strictly prohibited for 13 kinds of antibiotic powder injections that have been banned from use. The State Food and Drug Administration is continuing to investigate and gradually prohibit the injection of penicillin sodium salt, penicillin potassium salt, ampicillin, streptomycin sulfate and other powder injections to continue to use natural rubber stoppers.
At present, ordinary aluminum caps for powder injections and infusions are not easy to open due to large clinical use, and must be gradually replaced by easy-open caps such as aluminum-plastic composites. In the future, the registration of new ordinary aluminum cap production companies or workshops will not be completed.
Q: What preparations should companies make before implementing the Measures?
A: First of all, business leaders should pay great attention to the study and implementation of “Order No. 21” and realize that the implementation of the registration system for pharmaceutical packaging materials is an important way for the production, management and use of pharmaceutical packaging materials in China to be standardized and legalized, and to ensure the quality of medicines. The basic guarantee for the implementation of GM P management.
Second, we must increase the sense of urgency and sense of crisis. On the basis of a thorough understanding of the spirit, consciously in accordance with the terms of the existing product control checks, identify gaps, develop corrective measures in order to meet the standards within the time limit for registration.
Third, we must increase scientific research, accelerate the upgrading of products, and adjust the product structure. The "Procedure" stipulates that it is an illegal act to continue production, operation, and use of drugs and packaging materials that have been explicitly phased out. Severe penalties are imposed on the drugs and packaging materials that have been prescribed for a time limit. Therefore, the adjustment of product structure of related companies must be placed on the agenda of important issues to speed up the research and development of new drug packaging products that are suitable for different drug requirements.
In order to continuously improve product quality, packaging materials companies must combine with pharmaceutical companies to strengthen stability testing of packaging materials and pharmaceuticals. At the same time, we must attach importance to improving the level of design of pharmaceutical packaging to meet the needs of the rapid development of drug classification and health care products.
Q: What are the basic conditions for drug packaging materials and containers when they register?
A: According to the "Regulations", registered companies must meet the specific requirements of "institutional personnel", "factory facilities", "equipment", "materials", "production and quality management" and other eight areas (60) to score points. Formal item acceptance. The total score is set to 600 points. Each major item must reach more than 70% of the total score.
Pharmaceutical packaging companies must establish production and quality management agencies. The person in charge of production and quality must have relevant professional qualifications and management experience. The person in charge of the department should have a relevant college degree or above and have the ability to handle production and quality issues. Other personnel involved in production operations and quality inspections must be properly equipped.
Pharmaceutical packaging companies must have a clean production environment. The overall layout of the factory area must be reasonable, and all hidden dangers that may cause product contamination should be eliminated. The layout within the factory shall comply with the requirements of the relevant product's process flow and air cleanliness. In particular, the cleanliness level of the Class I pharmaceutical packaging must be the same as the cleanliness of the packed pharmaceuticals.
Equipment is an important tool for ensuring product quality. The equipment should be easy to clean, disinfect or sterilize and reduce pollution. In particular, equipment that produces Class I products must have good corrosion and chemical resistance. At the same time, a set of management systems for installation, operation, maintenance, and maintenance must be established.
A management system shall be established for the purchase, storage and use of materials. The materials used in the production of pharmaceutical packaging must be purchased from the units that meet the regulations, and the purchased materials must meet the national legal standards or other relevant standards. The imported raw materials should have the quarantine report of the port quality inspection department. Materials with different chemical and physical properties should be stored separately, used on schedule and reviewed on schedule. In particular, the label and instruction manual must be strictly managed.
When registering, it is necessary to have detailed production and quality management systems and documents as required.
Q: How to register?
A: The registration procedures for pharmaceutical packaging materials and containers are as follows:
The competent authority for the registration of pharmaceutical packaging materials is the State Drug Administration, which administers the specific registration work.
The Registration Department of the State Drug Administration, on behalf of the State Drug Administration, directly accepts the application and approval of imported pharmaceutical packaging materials and the review application for review of Type I pharmaceutical packaging materials, and issues the review task, quality testing plan for drug packaging materials, and organizes drug packaging and packaging countries. The formulation of standards, approval of registration and certification.
The provincial drug administration authority is authorized to manage the application of Class I drug packaging materials and complete the preliminary examination, and directly accept applications for Type II and III drug packaging materials.