Introduction and enlightenment of foreign remote inspection mode of pharmaceutical production
- VernacularTitle:国外药品生产远程检查模式介绍及启示
- Author:
Yangfan SHI
1
;
Jianan FU
1
;
Jianzhou YAN
1
;
Rong SHAO
1
Author Information
1. National Drug Policy and Medical Industry Economy Research Center，China Pharmaceutical University，Nanjing 211198，China
- Publication Type:Journal Article
- Keywords:
remote inspection of pharmaceutical production;
application situation;
implementation process;
inspection
- From:
China Pharmacy
2023;34(4):385-390
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To provide reference for the construction of remote inspection mode of pharmaceutical production in China. METHODS By combing the guidance documents of remote inspection and related pilots issued abroad， the experience of constructing remote inspection mode of pharmaceutical production was summarized. RESULTS & CONCLUSIONS Typical foreign countries and regions have carried out remote inspection pilots all over the world， and clearly defined the application situation， implementation process， inspection techniques and related points for attention of remote inspection of pharmaceutical production. In terms of application， the European Union pointed out four specific applicable situations， including travel restrictions， while the United States stipulated that remote inspection was applicable to pre-approved inspection and so on. In terms of the implementation process， the United States developed a four-step method of remote inspection， while the European Union has defined the specific implementation process of remote inspection in more detail. In comparison， Japan paid more attention to the remote inspection process of production documents. In terms of inspection techniques， the European Union used 360° cameras， Matterport 3D technology and document review software to realize the remote inspection of production sites and production documents. In terms of attention points for remote inspection， the United States required that access rights should be set for information sharing to avoid information disclosure. Both the European Union and the United States required inspectors to be trained and equipment inspected before remote inspection. It is suggested that China should formulate unified guidelines for remote inspection of pharmaceutical production， clarify the applicable situations， and formulate the implementation process of remote inspection of pharmaceutical production with reference to the opinions of drug manufacturers. In addition， intelligent remote inspection technology can be used in combination with the information construction level of drug manufacturers， and remote inspection training program can be formulated to cultivate professional remote inspection team.
