Jenny about … GxP — Risk of the unknown
The production of medical devices and medicinal products follows well established procedures, at least from a GxP point of view. Implementing GxP principles is demanding, but doable. But is this “fair-weather GxP” enough to provide protection against events unknown to date? In my experience, the answer is no.
If an unknown event really does occur, employees are no longer tempted to choose the “least wrong option” or, even worse, to start improvising. After all, by defining option X, the company has already decided on the option applicable for this case while instructing employees what to do.
For companies, the challenge is to put these options in the right positions of the process-flow and to make sure they are linked to the adequate instructions. The instruction must be designed such as to prevent the affected batch/product from slipping under the radar and reaching customers or patients in the “normal” way. As a result, companies can sustainably guarantee efficient, effective protection against the consequences of “unknown risks”.
■ Dr. Hans-Beat Jenny
As a former Deputy Director of Swissmedic, Dr. Hans-Beat Jenny is an expert on GxP matters and has decades of industry experience. For a long time, the chemist with a doctorate degree had been involved in the research and quality assurance of a Basel pharmaceutical company, before taking over management of the Drug Inspection Agency of Northwestern Switzerland and later the Sector Licensing of Swissmedic. Jenny has been working as a consultant since his retirement in 2016.