Machine translation: this English text was automatically translated from the original Dutch article. If anything is unclear or differs, please refer to the Dutch original.
Event language: This event was held in Dutch.
On 7 November 2025, impurities took centre stage during the annual GMP Theme Day, and several Dirty Secrets were revealed.
One presentation addressed the development of a holistic Contamination Control Strategy using a CCS tool.
Impurities also play an important role in the early development of a product. This was explained in greater detail from a CMC perspective.
Impurities can originate not only from the product itself, but also from manufacturing materials or primary packaging, entering the product in the form of Extractables & Leachables.
After the break, the programme continued with a presentation on Elemental Impurities that included an enjoyable quiz. The winner went home with a delicious chocolate letter.
The selection and management of CMOs in relation to technology transfer were then discussed.
Several presentations from the ECA conference on Annex 22 were summarised, prompting the question: is AI the future?
The day concluded with an update on ICH Q5, followed by a case study and panel discussion on “Impurities in the Spotlight—GMP’s Dirty Secrets”.
It was a successful day, offering insights from several perspectives into how to identify, reduce and prevent product impurities.