Change Notification - Change evaluation

Change evaluation

This change has been reported to the Austrian Authorities. Layout, construction and processes of the new facility have been designed in accordance with applicable laws and jurisdiction. Layout, construction and processes of the new facility were designed in accordance with applicabel laws and jurisdiction.

The new productin site will enable us to operate at a high level of current GMP quality standards for the manufacturing of active ingredients. For final manufacturing steps cleanrooms in class C will be available.

Currently used processes and equipment will be transferred to the new facility. Transfer of products and equipment will be performed under controlled conditions. To provide continuously high quality products the trained personnel engaged in the current sites will be employed in the new site.

As soon as the Manufacturer's Authorization for the new site will be available piCHEM will provide the documents to its customers.

Please contact us, if you need more information!