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Process optimisation

Change management

If changes are necessary after an increase in scale or the issuance of the marketing authorisation, we set out possible solutions entailing fast authority approval.

Part of the changes may be necessary, for example due to an inevitable change of substance supplier, equipment, or packaging material. Generally, these changes can be solved by a technology modification. In these cases, revalidation of the production or packaging processes is also necessary.

The other part of the changes is of economic aspect, e.g. changes affecting the design of the finished product. We decide on what intervention is necessary during the manufacturing and packaging of the product taking the conditions into account.

In case of every change, we ensure the consistency of the quality characteristics of our products and the legitimate transition of the modifications in the registration by proceeding complying with the company's quality management system.