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GMP News

BioPhorum Survey on -40 °C Drug Substance Storage Practices

A new BioPhorum publication summarizes the results of a 2025 cross-industry survey on -40 °C storage practices for biologic drug substance and provides insights into current industry approaches, risks, and best practices.

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GDP Non-Compliance Report: No Responsible Pharmacist

The Competent Authority of France (ANSM) has posted a new Statement of Non-Compliance with GDP in the EudraGMDP database. According to the report, the company's responsible pharmacist and deputy ceased their activities. However, the company did not appoint replacements or notify ANSM of such appointments.

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Ph. Eur. Update on Rubber Closures

A revised version of the Ph. Eur. chapter 3.2.9. Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders has been published in Pharmeuropa 37.4. The comment deadline is 31 December 2025.

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