Literature


Implementing Fast Re-inspections On The Companies
DATE: 2015-01-05

2-Implementing fast re-inspections on the companies that have passed the inspections by mainstream drug regulating institutions of Europe and America

 

As provided by CFDA’s Notice on Questions Related to Promote Medical and Pharmaceutical Industry Upgrades by Accelerating the Implementation of Newly Revised Quality Management Standard for Drug Production (GSYJA [2012] No.376), company GMP inspection process can be accelerated by executing re-inspection procedure on the companies that have passed the inspections by mainstream drug regulating institutions of Europe and America.

 

For instance, Guangdong provincial administration has inspected and re-inspected the following companies according to the requirements of relevant documents and confirmed their compliance to the 2010 version of GMP: Shenzhen Lijian Pharmaceutical Co., Ltd., Zhuhai United Laboratories Pharmaceutical Co., Ltd. and Titan Pharmaceutical Co., Ltd. (Guangdong).

 

The author holds that such an acceleration procedure is of positive significance. It can both save administrative and company resources and push forward companies’ initiative of improving their quality management to highlight the concept that quality management can also generate benefits. It should be understood, however, that not all international regulatory institutions provide reassuring regulating efforts, which makes it necessary to view the issue with dialectics and prudence.