Heavy! The General Department of the State Administration publicly solicits the announcement of the "Quality Management Standards for the Production of Pharmaceutical Excipients" and "Quality Management Standards for the Production of Pharmaceutical Package Materials" (draft for comments)
Release time:
2024-10-25
Durst DST Regulation Group noted that on July 18, 2024, the General Department of the State Drug Administration issued two drafts for comments at the same time, which are on the "Quality Management Standard for the Production of Pharmaceutical Excipients" and the "Quality Management Standard for the Production of Pharmaceutical Packaging Materials". This is the relevant production quality management standard issued by NMPA after the related review of pharmaceutical excipients and packaging materials, requiring feedback through electronic E-mail before August 20, 2024.
Durst DST Regulation Group noted that on July 18, 2024, the General Department of the State Drug Administration issued two drafts for comments at the same time, which are on the "Quality Management Standard for the Production of Pharmaceutical Excipients" and the "Quality Management Standard for the Production of Pharmaceutical Packaging Materials". This is the relevant production quality management standard issued by NMPA after the related review of pharmaceutical excipients and packaging materials, requiring feedback through electronic E-mail before August 20, 2024.
To strengthen the pharmaceutical excipients, pharmaceutical packaging materials quality supervision related matters are announced as follows:
1. pharmaceutical excipients, pharmaceutical packaging materials production enterprises to establish a sound quality management system
(I) implement the main responsibility of product quality.Pharmaceutical accessories and pharmaceutical packaging materials production enterprises shall establish and improve the quality management system, formulate detailed management documents, operating procedures and records, equip institutions and personnel suitable for the production scale, regularly evaluate the quality of pharmaceutical accessories and raw materials used by pharmaceutical packaging materials production enterprises, and organize production according to the prescription process through related evaluation, each batch of products shall be inspected according to the quality standards that have passed the related review, and shall be released after being reviewed and approved by the quality management department. For the production and export of pharmaceutical excipients and pharmaceutical packaging materials, the products shall meet the quality standards of the importing country (region).
(II) strict change quality management.Pharmaceutical excipients and pharmaceutical packaging materials manufacturers shall establish a change management system in accordance with the requirements of the "Pharmaceutical Excipients Production Quality Management Regulations" and "Pharmaceutical Package Materials Production Quality Management Regulations", and determine the changes in the production process of pharmaceutical excipients and pharmaceutical packaging materials based on risks. The category of the corresponding research shall be carried out and implemented after the joint approval of the quality management department and the department responsible for product registration.
(III) strengthen external communication and collaboration.Pharmaceutical excipients and pharmaceutical packaging materials manufacturers shall cooperate with drug marketing license holders to carry out audit, open relevant places or areas, and provide true, effective and complete documents, records and other relevant materials. In the event of changes in the production process, the source of raw materials, etc., which may affect the quality of pharmaceutical excipients and packaging materials, the corresponding assessment shall be carried out on the initiative and the holder of the drug marketing license shall be notified in a timely manner.
(IV) strengthen entrusted production management.If the registrant of pharmaceutical excipients and pharmaceutical packaging materials intends to entrust production, it shall declare and clarify the main body of production in strict accordance with the relevant procedures of the related review, and organize production in accordance with the relevant requirements of the related review.
2. Drug Marketing Authorization Holders Strengthen Material Quality Management
(V) implement the main responsibility of drug quality.The drug marketing license holder shall improve the quality management system, strictly manage the use of pharmaceutical excipients and drug packaging materials, evaluate and approve all pharmaceutical excipients and drug packaging materials suppliers (including production enterprises and distributors, the same below) required for the production of drugs, establish supplier quality files, strictly carry out in-factory inspection according to the requirements, and regularly carry out quality review and analysis, Ensure that the pharmaceutical excipients and drug packaging materials needed for the production of drugs meet the medicinal requirements.
(VI) strengthen supplier audit.The holder of the drug marketing license shall, in accordance with the requirements of the "quality Management Standard for the production of Pharmaceutical excipients" and "quality Management Standard for the production of Pharmaceutical packaging materials", regularly carry out quality assessment on the suppliers of pharmaceutical excipients and pharmaceutical packaging materials, and regularly conduct on-site audit on the quality management system of the suppliers of major pharmaceutical excipients and pharmaceutical packaging materials (especially the production enterprises) to ensure the quality and safety of drugs.
(VII) strengthen the material quality control.The holder of the drug marketing license shall review the quality control and inspection and release capabilities of the pharmaceutical excipients and pharmaceutical packaging materials manufacturers. If the pharmaceutical excipients and packaging materials required for the production of drugs involve entrusted inspection, the drug marketing license holder shall review the quality control ability of the entrusted inspection institution in accordance with the quality management standards for the production of pharmaceutical excipients and the quality management standards for the production of pharmaceutical packaging materials. If the requirements are not met, the drug marketing license holder shall stop using the relevant pharmaceutical excipients and packaging materials.
(VIII) strengthen supplier change management.The drug marketing license holder shall sign a quality agreement with the main pharmaceutical excipients and drug packaging material suppliers, timely grasp the changes of the pharmaceutical excipients and drug packaging materials used, study and evaluate the impact of the changes on the quality and stability of the drug, and carry out corresponding research in accordance with the requirements of drug change management, and implement or report after approval and filing.
3. drug regulatory authorities strengthen supervision and management
(IX) strengthen supervision and inspection.The provincial drug supervision and administration department shall strengthen policy publicity, urge the production enterprises of pharmaceutical excipients and drug packaging materials to conduct self-examination, and further improve the quality management level according to the requirements of standard specifications. The provincial drug supervision and administration department shall, in combination with the relevant information of enterprises and products, carry out daily supervision and inspection on the production enterprises of pharmaceutical excipients and drug packaging materials, and carry out extended inspection when necessary; according to the actual needs of supervision and the principle of risk management, Carry out random inspection on the quality of pharmaceutical excipients and drug packaging materials produced and used by drug marketing license holders, drug manufacturers, pharmaceutical excipients and drug packaging materials manufacturers.
(X) strengthen risk handling and investigate and deal with illegal acts.The provincial drug supervision and administration department shall impose penalties in accordance with the provisions of Article 126 of the Drug Administration Law if it is found that the relevant enterprises fail to comply with the production quality Management Standard for Pharmaceutical excipients and the production quality Management Standard for Pharmaceutical packaging materials. Notify the provincial drug supervision and administration department of the place where the relevant drug marketing license holder is located to stop using the relevant products. Submit the inspection conclusion to the Drug Examination Center of the State Drug Administration through the information registration platform, and put forward to adjust the corresponding product registration status of disposal recommendations. The Drug Examination Center of the State Food and Drug Administration shall adjust the registration status of the corresponding product in a timely manner (for example, adjust "A" to "I") based on the inspection conclusions and disposal recommendations.
(11) Strengthen information sharing.Through the information registration platform, the State Food and Drug Administration will share the information of pharmaceutical excipients and pharmaceutical packaging materials through the associated review to the provincial drug supervision and administration department where the enterprise is located. If the provincial drug supervision and administration department finds that the pharmaceutical auxiliary materials and pharmaceutical packaging materials production enterprises no longer have the corresponding production conditions, it shall be submitted to the drug examination center of the State Drug Administration, and the drug examination center shall conduct unified information management.
(12) Other matters.This announcement will be implemented from the date of 2025. Before the formal implementation, the production enterprises of pharmaceutical excipients and pharmaceutical packaging materials shall timely improve the facilities and equipment and improve the quality management system to ensure compliance with the requirements of the production quality management standards of pharmaceutical excipients and pharmaceutical packaging materials. From the date of formal implementation of this announcement, the former State Food and Drug Administration "on the issuance of" pharmaceutical excipients production quality management norms "notice" (State Food and Drug Administration an [2006] 120) repealed.
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