Consultancy to support GMP/GDP-relevant tasks is widespread in the manufacture, testing and distribution of active ingredients and pharmaceuticals. Careful selection of offered consultancy service as well as transparent planning and control of the consultancy support are required.
What are the options for structured selection, contracting and performance shaping?
The new article „Support by Consultants in the Pharmaceutical Industry“ (German language) by Dr. Martin Melzer, Principal Consultant of gempex GmbH, published in pharmind 06-2023, shows the possibilities and limits of consultancy support. Important key points are explained from the offer over the contract design up to the result review of the supplied services. Theoretical background is provided and models of cooperation are discussed. This makes it possible to check all essential framing conditions and thus to set the course for successful support in the best possible way.
Content keypoints are:
- Support and their limits
- Suitability of the consultancy
- Code of Conduct of the consultants
- Consulting approaches
- Principal-Agent Theory
- The consultancy offer
- Consultation - from inquiry to conclusion
- Consultancy - implementation and performance review
The German language article is available for download on GMP Knowledge.
Dr. Martin Melzer will be happy to answer any questions on the topic of "Quality of GMP Consultancy" via contact@gempex.com.