Fulfilling Annex I in sterile drug production: when to use automatic loading and unloading systems for freeze dryers

Sterile drug production has always been a challenging task to perform in the pharmaceutical industry.
There are many requirements to fulfill: to assure product quality, to protect the operator when potent
compounds are present, to achieve high levels of efficiency,.…. And all of them must comply with the
existing pharmaceutical regulations. In Europe, the main directives to follow are 2001/83/EC and
2017/1572. Annex I of these guidelines for CGMPs was modified in 2022 and it has agitated the sector
as human intervention is explicitly not accepted at all under class A conditions. This article will analyse
how to address these challenges in different scenarios.

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