On June 18, 2013, the Shandong Provincial Food and Drug Administration issued the Administrative Measures for Packaging Materials and Containers for Direct Contact with Drugs in Shandong Province. The administrative measures shall be implemented on August 1st and apply to units and individuals engaged in the production, use, inspection and supervision of pharmaceutical packaging materials within the administrative area of ​​Shandong Province.
The purpose of this method is to further standardize the management of drug packaging materials, improve the quality of drug packaging materials, and ensure the safety of public drug use.
Chapter I General Provisions Article 1 regulates the management of packaging materials and containers (hereinafter referred to as drug packaging materials) that are in direct contact with drugs, improves the quality of drug packaging materials, and protects the safety of public drug use, according to the "People's Republic of China Drug Administration Law" and its implementation. Regulations, "Management Methods for Packaging Materials and Containers Directly in Contact with Drugs," and other laws and regulations stipulate that the present Measures shall be formulated in accordance with the actual situation in our province.
Article 2 "Packaging materials" as used in these Measures refers to the packaging materials and containers for direct contact with pharmaceuticals used by pharmaceutical production enterprises and preparations prepared by medical institutions.
According to the characteristics and risks of drug packaging products, drug packaging products are divided into high-risk varieties and general varieties. High-risk varieties refer to packaging materials and containers for injections, ophthalmic preparations, aerosols, powder aerosols, and the like. Other varieties are general varieties.
Article 3 All units and individuals engaged in the production, use, inspection and supervision of pharmaceutical packaging materials within the administrative area of ​​this province shall abide by these Measures.
Article 4 The supervision and management of pharmaceutical packaging materials shall be conducted in accordance with the principle of territorial supervision and shall adopt a hierarchical responsibility system.
The Shandong Provincial Food and Drug Administration (hereinafter referred to as the Provincial Bureau) is responsible for the supervision and management of pharmaceutical packaging materials in the province. The municipal food and drug supervision bureau (hereinafter referred to as the municipal bureau) is responsible for the supervision and administration of the drug packaging materials within its jurisdiction, and is responsible for formulating the daily supervision and inspection plans and organizing them for implementation. The county (city, district) level Food and Drug Administration (hereinafter referred to as the county bureau) shall be responsible for the day-to-day supervision and inspection of pharmaceutical packaging material manufacturing enterprises under the guidance of the municipal bureau.
Chapter II Administration of Pharmaceutical Packaging Materials Article 5 The production of pharmaceutical packaging materials shall obtain the corresponding Registration Certificate for Pharmaceutical Packaging Materials according to law.
Article 6 Pharmaceutical packaging manufacturers must be responsible for product quality. Strictly implement the "General Rules for the Examination of Pharmaceutical Packaging Materials Production Site", establish and improve a quality management system, strengthen the audit of suppliers of raw materials for production, strictly control the quality of raw materials, organize production according to the prescription process of product registration approval, and standardize the preparation of product batch numbers. Ensure product quality and stability.
Article 7 Pharmaceutical packaging material production enterprises shall be equipped with inspection and testing instruments and equipment that are compatible with the production of products. In strict accordance with the registered and approved quality standards, each batch of products shall be inspected and sold only after being qualified.
Article 8 Pharmaceutical packaging manufacturers shall cooperate with suppliers of pharmaceutical packaging materials to carry out supplier audits. When changes occur in formulas, production processes, sources of raw materials, etc., which may affect the quality of the drug packaging materials, quality risk assessment should be actively carried out and the units that use them should be notified in writing in a timely manner.
Article 9 The production and management of pharmaceutical packaging materials shall adopt a production reporting system for pharmaceutical packaging materials and a supervision and inspection system for the production of pharmaceutical packaging materials. The drug packaging material production reporting system includes the annual report on the production of drug packaging materials and the report on change of important issues. The supervision and inspection system for the production of pharmaceutical packaging materials refers to the supervision and inspection of the production and quality management of pharmaceutical packaging materials by the food and drug supervision and administration departments.
Article 10 The drug packaging material production enterprises shall carry out self-examination against the "General Requirements for the Examination of Pharmaceutical Packaging Materials Production Site" each year to form the "Annual Report of Drug Packaging Materials Production Enterprises of Shandong Province", and report to the local county bureau of the locality before December 10, and the county bureau shall Consolidate the relevant information and report it to the PM. The report shall include the following contents: (1) the status of the company's organization, quality and production management, major production facilities, equipment, and inspection conditions, and whether there are any changes; (2) product formulation and production process and changes; ( c) The situation of accepting the supervision and inspection and the implementation of the rectification requirements; (4) The sampling inspection situation of the product quality supervision, and the rectification of the defective items and hidden troubles that are not qualified; (5) Tracking, variety, and quality of the products, batches, and quality produced in the year Yearly returns and disposals, etc.; (6) Cleanliness testing of clean rooms (districts) of pharmaceutical packaging companies that have cleanliness requirements; (vii) Other quality-related information.
Article 11 The drug packaging material manufacturing enterprise shall change the enterprise name, production site, raw material production area and supplier, product formulation and production process, key equipment, registration standards, etc., and submit it to the municipal bureau and county within 10 working days after approval. The Bureau submitted the “Report on the Changes in Important Issues for Production of Pharmaceutical Packaging Material in Shandong Provinceâ€. At the same time, submit the product quality risk assessment report after the change.
Article 12 The Municipal Bureau shall, before December 20 of each year, report the supervision and management of pharmaceutical packaging material manufacturing enterprises within its jurisdiction to the provincial bureau, and report important conditions at any time.
Chapter III Management of the Use of Pharmaceutical Packaging Materials Article 13 The use units of pharmaceutical packaging materials shall select drug packaging materials that can ensure the quality of pharmaceuticals according to the characteristics of the drugs. Purchased drug packaging materials shall obtain the legal qualifications of the supplier, the "Pharmaceutical Packaging Material Registration Certificate," the inspection report and legal documents.
Article 14 The use units of pharmaceutical packaging materials shall strengthen the audit of the suppliers of pharmaceutical packaging materials. In accordance with the relevant requirements of the "Quality Control Practice for Pharmaceutical Production (2010 Revision)", drug packaging material manufacturing enterprises are regularly evaluated, and all purchased drug packaging materials and suppliers' files are established.
Article 15 Purchasers of pharmaceutical packaging materials shall purchase the pharmaceutical packaging materials in accordance with the registration standards, and use them only after meeting the standards. Items that cannot be self-checked temporarily can be commissioned for inspection.
In the process of use, quality problems should be reported to the City Council in a timely manner.
Article 16 The unit purchasing medicine and packaging materials shall sign a quality agreement with the supplier of medicine packaging materials, and shall promptly grasp the changes in the used medicine packaging materials, and study and evaluate the impact of the changes on the quality of medicines.
Chapter IV Supervision and Administration Article 17 The provincial bureau shall be responsible for the registration and re-registration applications of the whole province, the preliminary examination and on-site verification of the supplementary application for drug packaging materials.
Article 18 The supervision and inspection of pharmaceutical packaging materials is divided into daily supervision and inspection and due to inspection.
The daily supervision and inspection is a planned supervision and inspection of the production and quality management of drug packaging material manufacturing enterprises. Due to inspections, inspections are carried out on drug packaging material manufacturing companies that are suspected of violations of laws, regulations, product quality failures or quality accidents.
Article 19 The county bureau shall supervise and inspect the drug packaging material manufacturing enterprises in the jurisdiction within no less than two times per year; the municipal office shall inspect the high-risk variety of drug packaging and packaging materials enterprises no less than once per year. When necessary, it can be combined with other inspections such as registration of drug packaging materials on site. The supervision and inspection of units that use pharmaceutical packaging materials can be carried out together with the daily supervision and inspection of pharmaceuticals. According to the quality risk situation, the provincial bureau does not regularly organize the supervision and inspection of the production, distribution and use of pharmaceutical packaging materials in the province.
Article 20 Prior to the implementation of supervision and inspection, an inspection plan shall be formulated, the inspection standards shall be clearly defined, and the content and focus of the inspection shall be determined. The inspection personnel shall conduct on-site inspections in accordance with the inspection plan.
Article 21 When there are two or more inspectors on site, they shall be inspected in accordance with the following procedures: (1) Presenting the administrative enforcement certificates to the personnel in the inspected unit, and informing the purpose, scope, schedule of the inspection, and implementing the inspection Personnel; (2) Implementing on-site supervision and inspection according to the “General Rules for the Production of Pharmaceutical Packaging Materialsâ€, and recording the actual situation of on-site inspection; (3) Summarizing inspections, making clear inspection conclusions, and making “Shandong Pharmaceutical Packaging Materials Manufacturing Enterprise†"Supervisory Inspection Record Form", inspectors, the person in charge of the unit being inspected (or the quality attorney) signed and confirmed by both parties, and keep a copy of the company being inspected; (4) If the quality of the drug package product is found to be suspicious during inspection, it shall be carried out in accordance with relevant regulations. On-site sampling shall be sent to the pharmaceutical packaging and material inspection agency set up or determined by the provincial bureau. (5) After the inspection is completed, the inspection report and other related materials shall be reported to the sending unit.
Article 22 The supervision and testing system shall be implemented for the production and use of medicines and packaging materials. The medicine and packaging materials inspection agency set up or determined by the provincial bureau shall undertake the quality inspection of the medicine and packaging materials and issue an inspection report. The provincial bureau regularly publishes the results of random inspection of drug packaging materials, and handles the production and use units of unqualified drug packaging materials according to law.
Article 23 The municipal bureau shall establish and improve the supervision files of pharmaceutical packaging material manufacturing enterprises within its jurisdiction. The supervision files shall include qualification certificates for the production of drug packaging materials, relevant changes, on-site inspection records, product quality supervision and sampling inspection, violation of laws and regulations, etc.
Article 24 The food and drug supervision and administration department may conduct interviews with the relevant person in charge of the enterprise according to the problems found in the on-site inspection and supervision of random inspections and the results of risk assessment. The interview procedure implements the provisions of the “Shandong Province Drug-related Unit Interview System (Trial)â€.
Article 25 If the supervision and inspection finds that illegal production and use of pharmaceutical packaging materials are handled in accordance with laws and regulations such as the "Drug Administration Law," "Administration Regulations for the Administration of Drugs," and "Administrative Measures for Packaging Materials and Containers Directly in Contact with Drugs," and other laws and regulations.
Chapter V Supplementary Provisions Article 26 These Measures shall come into force on August 1, 2013 and shall be valid until July 31, 2015.
The purpose of this method is to further standardize the management of drug packaging materials, improve the quality of drug packaging materials, and ensure the safety of public drug use.
Chapter I General Provisions Article 1 regulates the management of packaging materials and containers (hereinafter referred to as drug packaging materials) that are in direct contact with drugs, improves the quality of drug packaging materials, and protects the safety of public drug use, according to the "People's Republic of China Drug Administration Law" and its implementation. Regulations, "Management Methods for Packaging Materials and Containers Directly in Contact with Drugs," and other laws and regulations stipulate that the present Measures shall be formulated in accordance with the actual situation in our province.
Article 2 "Packaging materials" as used in these Measures refers to the packaging materials and containers for direct contact with pharmaceuticals used by pharmaceutical production enterprises and preparations prepared by medical institutions.
According to the characteristics and risks of drug packaging products, drug packaging products are divided into high-risk varieties and general varieties. High-risk varieties refer to packaging materials and containers for injections, ophthalmic preparations, aerosols, powder aerosols, and the like. Other varieties are general varieties.
Article 3 All units and individuals engaged in the production, use, inspection and supervision of pharmaceutical packaging materials within the administrative area of ​​this province shall abide by these Measures.
Article 4 The supervision and management of pharmaceutical packaging materials shall be conducted in accordance with the principle of territorial supervision and shall adopt a hierarchical responsibility system.
The Shandong Provincial Food and Drug Administration (hereinafter referred to as the Provincial Bureau) is responsible for the supervision and management of pharmaceutical packaging materials in the province. The municipal food and drug supervision bureau (hereinafter referred to as the municipal bureau) is responsible for the supervision and administration of the drug packaging materials within its jurisdiction, and is responsible for formulating the daily supervision and inspection plans and organizing them for implementation. The county (city, district) level Food and Drug Administration (hereinafter referred to as the county bureau) shall be responsible for the day-to-day supervision and inspection of pharmaceutical packaging material manufacturing enterprises under the guidance of the municipal bureau.
Chapter II Administration of Pharmaceutical Packaging Materials Article 5 The production of pharmaceutical packaging materials shall obtain the corresponding Registration Certificate for Pharmaceutical Packaging Materials according to law.
Article 6 Pharmaceutical packaging manufacturers must be responsible for product quality. Strictly implement the "General Rules for the Examination of Pharmaceutical Packaging Materials Production Site", establish and improve a quality management system, strengthen the audit of suppliers of raw materials for production, strictly control the quality of raw materials, organize production according to the prescription process of product registration approval, and standardize the preparation of product batch numbers. Ensure product quality and stability.
Article 7 Pharmaceutical packaging material production enterprises shall be equipped with inspection and testing instruments and equipment that are compatible with the production of products. In strict accordance with the registered and approved quality standards, each batch of products shall be inspected and sold only after being qualified.
Article 8 Pharmaceutical packaging manufacturers shall cooperate with suppliers of pharmaceutical packaging materials to carry out supplier audits. When changes occur in formulas, production processes, sources of raw materials, etc., which may affect the quality of the drug packaging materials, quality risk assessment should be actively carried out and the units that use them should be notified in writing in a timely manner.
Article 9 The production and management of pharmaceutical packaging materials shall adopt a production reporting system for pharmaceutical packaging materials and a supervision and inspection system for the production of pharmaceutical packaging materials. The drug packaging material production reporting system includes the annual report on the production of drug packaging materials and the report on change of important issues. The supervision and inspection system for the production of pharmaceutical packaging materials refers to the supervision and inspection of the production and quality management of pharmaceutical packaging materials by the food and drug supervision and administration departments.
Article 10 The drug packaging material production enterprises shall carry out self-examination against the "General Requirements for the Examination of Pharmaceutical Packaging Materials Production Site" each year to form the "Annual Report of Drug Packaging Materials Production Enterprises of Shandong Province", and report to the local county bureau of the locality before December 10, and the county bureau shall Consolidate the relevant information and report it to the PM. The report shall include the following contents: (1) the status of the company's organization, quality and production management, major production facilities, equipment, and inspection conditions, and whether there are any changes; (2) product formulation and production process and changes; ( c) The situation of accepting the supervision and inspection and the implementation of the rectification requirements; (4) The sampling inspection situation of the product quality supervision, and the rectification of the defective items and hidden troubles that are not qualified; (5) Tracking, variety, and quality of the products, batches, and quality produced in the year Yearly returns and disposals, etc.; (6) Cleanliness testing of clean rooms (districts) of pharmaceutical packaging companies that have cleanliness requirements; (vii) Other quality-related information.
Article 11 The drug packaging material manufacturing enterprise shall change the enterprise name, production site, raw material production area and supplier, product formulation and production process, key equipment, registration standards, etc., and submit it to the municipal bureau and county within 10 working days after approval. The Bureau submitted the “Report on the Changes in Important Issues for Production of Pharmaceutical Packaging Material in Shandong Provinceâ€. At the same time, submit the product quality risk assessment report after the change.
Article 12 The Municipal Bureau shall, before December 20 of each year, report the supervision and management of pharmaceutical packaging material manufacturing enterprises within its jurisdiction to the provincial bureau, and report important conditions at any time.
Chapter III Management of the Use of Pharmaceutical Packaging Materials Article 13 The use units of pharmaceutical packaging materials shall select drug packaging materials that can ensure the quality of pharmaceuticals according to the characteristics of the drugs. Purchased drug packaging materials shall obtain the legal qualifications of the supplier, the "Pharmaceutical Packaging Material Registration Certificate," the inspection report and legal documents.
Article 14 The use units of pharmaceutical packaging materials shall strengthen the audit of the suppliers of pharmaceutical packaging materials. In accordance with the relevant requirements of the "Quality Control Practice for Pharmaceutical Production (2010 Revision)", drug packaging material manufacturing enterprises are regularly evaluated, and all purchased drug packaging materials and suppliers' files are established.
Article 15 Purchasers of pharmaceutical packaging materials shall purchase the pharmaceutical packaging materials in accordance with the registration standards, and use them only after meeting the standards. Items that cannot be self-checked temporarily can be commissioned for inspection.
In the process of use, quality problems should be reported to the City Council in a timely manner.
Article 16 The unit purchasing medicine and packaging materials shall sign a quality agreement with the supplier of medicine packaging materials, and shall promptly grasp the changes in the used medicine packaging materials, and study and evaluate the impact of the changes on the quality of medicines.
Chapter IV Supervision and Administration Article 17 The provincial bureau shall be responsible for the registration and re-registration applications of the whole province, the preliminary examination and on-site verification of the supplementary application for drug packaging materials.
Article 18 The supervision and inspection of pharmaceutical packaging materials is divided into daily supervision and inspection and due to inspection.
The daily supervision and inspection is a planned supervision and inspection of the production and quality management of drug packaging material manufacturing enterprises. Due to inspections, inspections are carried out on drug packaging material manufacturing companies that are suspected of violations of laws, regulations, product quality failures or quality accidents.
Article 19 The county bureau shall supervise and inspect the drug packaging material manufacturing enterprises in the jurisdiction within no less than two times per year; the municipal office shall inspect the high-risk variety of drug packaging and packaging materials enterprises no less than once per year. When necessary, it can be combined with other inspections such as registration of drug packaging materials on site. The supervision and inspection of units that use pharmaceutical packaging materials can be carried out together with the daily supervision and inspection of pharmaceuticals. According to the quality risk situation, the provincial bureau does not regularly organize the supervision and inspection of the production, distribution and use of pharmaceutical packaging materials in the province.
Article 20 Prior to the implementation of supervision and inspection, an inspection plan shall be formulated, the inspection standards shall be clearly defined, and the content and focus of the inspection shall be determined. The inspection personnel shall conduct on-site inspections in accordance with the inspection plan.
Article 21 When there are two or more inspectors on site, they shall be inspected in accordance with the following procedures: (1) Presenting the administrative enforcement certificates to the personnel in the inspected unit, and informing the purpose, scope, schedule of the inspection, and implementing the inspection Personnel; (2) Implementing on-site supervision and inspection according to the “General Rules for the Production of Pharmaceutical Packaging Materialsâ€, and recording the actual situation of on-site inspection; (3) Summarizing inspections, making clear inspection conclusions, and making “Shandong Pharmaceutical Packaging Materials Manufacturing Enterprise†"Supervisory Inspection Record Form", inspectors, the person in charge of the unit being inspected (or the quality attorney) signed and confirmed by both parties, and keep a copy of the company being inspected; (4) If the quality of the drug package product is found to be suspicious during inspection, it shall be carried out in accordance with relevant regulations. On-site sampling shall be sent to the pharmaceutical packaging and material inspection agency set up or determined by the provincial bureau. (5) After the inspection is completed, the inspection report and other related materials shall be reported to the sending unit.
Article 22 The supervision and testing system shall be implemented for the production and use of medicines and packaging materials. The medicine and packaging materials inspection agency set up or determined by the provincial bureau shall undertake the quality inspection of the medicine and packaging materials and issue an inspection report. The provincial bureau regularly publishes the results of random inspection of drug packaging materials, and handles the production and use units of unqualified drug packaging materials according to law.
Article 23 The municipal bureau shall establish and improve the supervision files of pharmaceutical packaging material manufacturing enterprises within its jurisdiction. The supervision files shall include qualification certificates for the production of drug packaging materials, relevant changes, on-site inspection records, product quality supervision and sampling inspection, violation of laws and regulations, etc.
Article 24 The food and drug supervision and administration department may conduct interviews with the relevant person in charge of the enterprise according to the problems found in the on-site inspection and supervision of random inspections and the results of risk assessment. The interview procedure implements the provisions of the “Shandong Province Drug-related Unit Interview System (Trial)â€.
Article 25 If the supervision and inspection finds that illegal production and use of pharmaceutical packaging materials are handled in accordance with laws and regulations such as the "Drug Administration Law," "Administration Regulations for the Administration of Drugs," and "Administrative Measures for Packaging Materials and Containers Directly in Contact with Drugs," and other laws and regulations.
Chapter V Supplementary Provisions Article 26 These Measures shall come into force on August 1, 2013 and shall be valid until July 31, 2015.
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