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Fulfilling Annex I in Sterile Drug Production: When to Use Automatic Loading and Unloading Systems for Freeze Dryers
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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Facilities & Equipment
Product Development
Sterile Prd