The implementation of a robust Quality Management System (QMS) is a key success factor for clinical development with the goal of reaching marketing authorization. As important as your QMS is during your product development phase, it’s equally important during your commercialization phase and through the product lifecycle. However, your quality work will change between the two phases depending on the type of company you are. In this blog, we explain the difference and provide an overview of the steps and the skills required for both phases so you can effectively bring your products to market.
First, we provide an overview of the differences in quality work, and therefore the requirements of your QMS between the Clinical and Commercial phase.
As a MAH, you have the overall accountability for the quality of the product, even if your supply chain is fully outsourced. This is established in the Annex 16 of EudraLex Vol 4 that defines GMP-activities in EU:
The ultimate responsibility for the performance of a medicinal product over its lifetime, its safety, quality and efficacy, lies with the marketing authorization holder (MAH).
On top of that, the EMA has also written a concept paper defining in the legislation where MAHs have an extended responsibility:
So, between the responsibilities you have, and the diverse requirements needed for different aspects of commercialization, what exactly are the questions you need to ask yourself to prepare? We have created an overview:
To prepare for your commercialization, ProPharma’s experienced consulting team will support and guide you with all the different aspects of GxP-environments. This includes:
If you want to discuss your specific case with an expert, please contact us.
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