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NMPA's Regulations on On-Site Inspection for Drug Registration

Posting Date：2021-09-01Views：
以下是该段内容的英文翻译： ---

Text Editor: Li Bin, Regulatory Affairs Manager

Image Editor: Administration Department

 

  From August 27 to 29, 2021, an expert team dispatched by the Center for Food and Drug Inspection of the National Medical Products Administration (NMPA) conducted an on-site inspection at our company for the quality and efficacy一致性评价 of a certain tablet formulation developed by us. 

 

▲ On August 27, the inspection team held the first meeting in the conference room of Shenyang Dasan Pharmaceutical Technology Co., Ltd.

 

▉ Inspection Activities

The three inspectors examined our company's quality management system from the perspectives of consistency, data compliance, and reliability. The inspection covered the original records of trial production and quality research for the product, chromatograms, material usage logs, instrument and equipment usage records, related validation documents, as well as performance and mechanical validation of the dissolution apparatus, computer system validation, and audit trails for the UV-Vis spectrophotometer and high-performance liquid chromatography (HPLC).

 

 

▉ Progress of Inspection

The three-day inspection focused on formulation/process research, quality research, and in vitro evaluation studies. Attention was also given to the source and use of the reference product, method transfer and technical transfer documentation, the establishment and validation of in vitro dissolution profiles, and comparative studies between the self-developed formulation and the reference product.

 

▉ Inspection Summary

The on-site inspection team's conclusion was that the formulation and process research, quality research, and sample preparation related to the tablet were generally consistent with the information provided in the company's application dossier.
 
The successful completion of this inspection reflects our company's consistent commitment to integrity, standardized management, and the pursuit of excellence. Building on the results of this inspection, we will deeply study the valuable suggestions provided by the expert team, continue to improve, and strictly implement the Drug Registration Regulation and related guidance documents issued by the NMPA to ensure that our R&D work remains controlled and compliant. We are committed to developing high-quality products that the country, the public, and our clients can trust!

 

 

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