Oct 5, 2022 · Implementation of MAM as a QC tool would facilitate advanced control strategies in line with ICH Q8 [1] and is supported by established and ...
EFPIA REGULATORY POSITION PAPER https://www.efpia.eu/media/676706/efpia- · regulatory-position-paper_mam-as-qc-tool_final.pdf. Page 18. 18. Acknowledgement.
In line with EU guidance and Regulation, all pharmaceutical products intended for use in European clinical trials have to be manufactured according to GMP.
Missing: 676706/ paper_mam- tool_final.
Some regulatory challenges exist for the introduction and acceptance of these method types. One challenge is the frequent lack of correlation between MAMs and ...
This article is a further elaboration of the EFPIA position paper published on the EFPIA website in October 2022 [13]. To allow MAM to be used in a QC ...
Apr 14, 2023 · The regulatory considerations of using MAM as a QC release and stability tool for biopharmaceuticals are discussed in a position paper published ...
We must ensure that the revised pharmaceutical legislation meets the needs of patients, carers, healthcare and public health systems, Member States and Europe's ...
Missing: 676706/ paper_mam- tool_final.
Apr 16, 2024 · EFPIA Use of Multi Attribute Method by mass spectrometry as a QC release and stability tool for biopharmaceuticals – regulatory considerations; ...
Jul 25, 2023 · EFPIA Use of Multi Attribute Method by Mass Spectrometry as a QC Release and Stability Tool for Biopharmaceuticals – Regulatory Considerations.
Jun 6, 2023 · Use of multi attribute method by mass spectrometry as a QC release and stability tool for biopharmaceuticals – Regulatory considerations. 2022.