MSD Animal Health Innovation
Marci has been working in Europe for eight years assuring the quality of veterinary R&D departments. She has managed QA teams supporting GLP and GCP studies as well as GMP areas for investigational veterinary medicinal products in Germany and France.
Before joining MSD Animal Health Innovation, Marci supported R&D activities at Boehringer Ingelheim Vetmedica in Ingelheim, Germany and St. Joseph, Missouri. Prior to that she worked at Novartis reviewing and releasing commercial batches for Human and Veterinary products. Marci began her QA career at a University veterinary diagnostic centre implementing a quality system compliant to ISO 17025.
Marci has a BSc in Zoology from Weber State University and an M.A. in Biology from the University of Nebraska at Omaha. She is a member of the Animal Veterinary Product Committee of the RQA , the German Quality Management Association, and the Animal Health Specialty Section of SQA in the US.
Investigational Veterinary Medicinal Products: Exempt or Not-exempt… is that the question?
According to VICH GL9, investigational veterinary products should be manufactured according to GMP wherever possible. Where does ‘wherever possible’ start and how does it end? GMP entails having knowledge and control of product manufacturing from qualification of incoming materials and validation of critical parameters, to release of the product by a Qualified Person all under a GMP manufacturing license. Are investigational veterinary products exempt from any of the GMP processes?
This presentation highlights some of the EU standards relevant to veterinary medicinal products for clinical trials. This includes, Directive EU 2001/82/EC as amended, EU GMP Guideline Volume 4 and Annex 13, as well as selected EU national requirements.
Participation and discussion is encouraged as not all countries manage veterinary medicinal products for clinical studies the same. We all benefit from sharing our experiences and interpretation whether you work with pharmaceutical or biological products, at a sponsor company or contract research organisation. Because after all, VICH GL9 is just a guideline…right?