No market introduction without validation. In this interview, Dr Claudia Papewalis and Dr Hans-Georg Eckert from Valicare GmbH explain what needs to be taken into account.
What does validation actually mean?
Dr Eckert: Validation is a quality tool of the legally binding GMP requirements. It is the final step in the product development process. At this point in time, companies have already invested a lot of time and money in the product. Hence it is crucial to prevent it from failing.
Dr Papewalis: Therefore, validation should be taken into consideration from the very beginning. However, especially with developers – mostly start-ups and universities – of new therapeutics such as ATMPs, this is often not the case.
What can you do about it?
Dr Eckart: Following the FDA guidelines “Process Validation: General Principles and Practices” of 2011, the current EMA guidelines (“Guidelines on Process Validation for Finished Products – Information and data to be provided in regulatory submission”) released on November 21, 2016 focus on early risk analysis. Pharmaceutical manufacturers are familiar with the requirements. They rather need help in putting together the extensive documentation.
Dr Papewalis: We see that developers have a large need for clarification and support. This is something we can offer at an early point in the process by combining validation expertise and professional know-how.
Do you have a practical example for us?
Dr Eckart: A customer experienced substantial problems with the audit due to unstructured validation documents. We developed a concept, qualified the equipment and validated an exemplary process including documentation in collaboration with this customer. This now enables him to transfer the process to further products.
Dr Papewalis: This is the objective of all Valicare services: at the end of the consultation, customers should not be left alone with a complex concept. We also accompany them during implementation and with trainings. Because they can only achieve a successful market introduction when they understand what is required for a successful validation.
Dr. Ellen Sons-Brinkmann
+49 69 7909-350