Masterarbeit

Post-Authorisation Implementation of a New Finished Product Manufacturer - A Case Study Analysis ***

Judith Rechler (2025)

Summary

Language: English

Medical shortages have become a global problem for the quality and continuity of patient care. Improving the availability of medicines has become a key principle in the European Union. Several studies conducted in the past show that these are often quality and manufacturing related issues. In 2023 the European Medicines Agency and Heads of Medicines Agencies published recommendations for the industry to reduce medical shortages. 

In order to stabilize the supply chain, one solution could be to add a second finished product manufacturer or change to a more reliable one. The purpose of this thesis is to derive a best practice concept on how to include a finished product manufacturer during the lifecycle of a medicinal product. Five case studies by a contract development and manufacturing organization, focusing on generics, are analysed. The following topics are considered: variations, deficiency letters, batch concepts and stability requirements. Moreover, the hurdles and tasks of other departments are presented through short interviews. In addition, the respective changes in Commission Regulation (EU) 2024/1701 amending the Variations Regulation (EC) No 1234/2008 and the variations classification guideline are evaluated.

The case studies demonstrate the complexity of a change in finished product manufacturer and the different variations that can be included in such a change. The finished dosage form and manufacturing process are important for the correct classification. The best practice concept developed incorporates not only the official requirements, but also the experience gained from the cases analysed.

For a change in finished product manufacturer more clarity and harmonisation with other guidance could be helpful to avoid different understanding, not only between the applicant and the regulatory authorities, but also between different authorities. 

In conclusion, a change in finished product manufacturer needs to be well-planned by experts with extensive knowledge of the product and manufacturing process in order to avoid supply shortages. 

Pages: 47

Annexes: 4, Pages: 34