By Bilel Khedir and Dalenda Bouslah, Opalia Recordati
The authors discuss important aspects of tech transfer (the project management plan, gap analysis, risk assessment, and more) and share the notable FDA and WHO guidelines related to each area.
This article discusses recent initiatives from the FDA, such as KASA, PQ/CMC, and the ICH SPQS. Let's look at how they could be the early birds of the paradigm shift from electronic CTDs to digital CTDs. The article also addresses what steps the industry should be taking in parallel with the authorities in preparation for this (very near) digital future.
Under the FDA and other regulatory bodies, the biopharma and medical device industries have been using computer software and systems validation testing methodologies to validate software within the GxP environment. Let's dive into the use of agile methodology in the planning phase of a software development plan.
Characterization is essential to understand the impact following process changes and successful biosimilar development. Here, we provide best approaches for comparability studies.
