raw materials and auxiliary materialsGMPThe newly revised regulations on the quality management of pharmaceutical excipients production stipulate that the quality of raw materials is the cornerstone of ensuring drug safety and effectiveness throughout the entire process of drug production.2025 year 1 moon 2 On [date], the National Medical Products Administration issued the "Good Manufacturing Practice for Drugs" with great weight（2010 The Appendix of Medicinal Excipients, revised annually, is from 2026 year 1 moon 1 Formally implemented from [date], at the same time,2006 The Notice on Issuing the Quality Management Standards for the Production of Medicinal Excipients, issued in [year], is abolished. The update of this regulation pertains to raw materials and auxiliary materialsGMPThe verification work has brought new and stricter requirements.

Newly released appendices for pharmaceutical excipientsChapter 13, Article 79, comprehensively covers key areas such as quality management, institutions and personnel, factories and facilities, equipment, materials and products, confirmation and verification, document management, etc. In terms of confirmation and verification, regulations clearly stipulate that enterprises must conduct comprehensive and in-depth verification of their factories, facilities, equipment, and production processes to ensure that they can continuously and stably produce products that meet the intended use and registration requirements under established raw materials, equipment, and process conditions. Once there are changes in factors that have a critical impact on product quality, such as the replacement of raw materials, updates to production equipment, adjustments to production processes, or improvements to inspection methods, enterprises must promptly carry out confirmation or verification activities, and if necessary, report to the drug supervision and management department for approval.For example, in the validation of the production process of active pharmaceutical ingredients, the pre validation method should usually be prioritized; But if it is difficult to obtain ready-made data from repetitive production due to low production frequency, small batch quantity, or changes in production process, synchronous verification can be implemented.

Cleaning verification is also a key part emphasized by regulationsEnterprises must verify their cleaning methods to effectively demonstrate their cleaning effectiveness and prevent pollution and cross contamination. In the verification process, it is necessary to comprehensively consider various factors such as the usage of the equipment, the characteristics of the selected cleaning and disinfecting agents, the sampling method and location, the sampling recovery rate, the properties and limits of the residue, and the sensitivity of the residue testing method.

The material management process has also been given very high attentionEnterprises need to conduct regular quality assessments of the raw materials used in the production of raw materials, strictly organize production according to the information registered on the raw material packaging registration platform of the National Medical Products Administration's Drug Evaluation Center, and conduct strict inspections on each batch of products according to quality standards. Only after being reviewed and approved by the quality management department can the products be released. This requires enterprises to establish a comprehensive and traceable quality management system throughout the entire process of raw material procurement and use, ensuring that the source of each batch of raw materials is clear and the quality is reliable.

Provincial drug regulatory departments will also utilize the information from the original auxiliary package registration platform of the drug review center to address the registration status within the administrative region“A”Raw material production enterprises that have undergone technical review shall carry out supervision and inspection, urging them to strictly produce according to their registered information. At the same time, quality inspections of raw materials may be conducted based on actual regulatory needs and risk management principles. Enterprises that violate regulatory requirements will be severely investigated and dealt with in accordance with relevant provisions of the Drug Administration Law.

Suzhou Yikang Environmental Testing Co., Ltd. provides professional raw materials and accessoriesGMPVerification services, facing such comprehensive and strict regulatory changesEnterprises in raw materialsGMPIn the verification work, it is necessary to accurately grasp the key points of regulations, from the formulation of verification plans, the implementation of on-site verification, to the management of document records, ensuring compliance in every link. Our raw materialsGMPVerification services closely adhere to the latest regulatory requirements. With a professional regulatory interpretation team and rich project practical experience, we provide you with a one-stop solution from policy consultation to verification implementation, helping you cope with regulatory changes calmly and ensuring that the quality of raw material production is fully controllable and compliant without worries.