Definition and Qualification of a New ISO7 Manufacturing Suite

In order to broaden its current product portfolio, our customer wanted to expand its production capacity with the construction of a new ISO 7-certified manufacturing suite at its existing manufacturing site. The new ISO Class 7 suite aimed to provide a suitable manufacturing environment to produce pharmaceutical ingredients.

Genipro was commissioned to provide both technical writing and execution of GMP qualification documents for a new manufacturing suite offering an ISO 7 level of air cleanliness. The new ISO Class 7 suite was to be designed, built, qualified, operated and maintained by the customer in compliance with European and Canadian pharmaceutical regulatory requirements and expectations, as well as local building codes and regulations.

The main challenge was to adapt to the client's schedule in order to quickly finalize the qualification work as soon as the commissioning work was completed. The qualification demonstrated that the new premises met all specifications and requirements.