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July 07, 2020
The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published a new general chapter (2.6.32) in the European Pharmacopoeia (Ph. Eur.) supplement 10.3.
July 02, 2020
It is important to consider the feasibility, benefits, and limitations of each type of audit in advance.
There is much to learn from the COVID-19 pandemic, but future success may hinge upon the capacity for regulatory bodies to harmonize approaches.
483s and Warning Letters Point to Inadequate Quality Oversight
Real-time monitoring and the principles of quality by design were used to optimize an OSD coating process.
The authors present a simple way to qualify a swab-sampling procedure for its ability to recover residues of a small-molecule API from cleaned equipment surfaces.
July 01, 2020
FDA can better monitor quality production of domestic versus foreign firms.
Investigating the root causes of OOS conditions, product defects, and batch failures requires a systematic, thorough approach.
Appropriate analytical assays are needed to determine and ensure that biosimilar critical quality parameters are on track.
June 30, 2020
The company now offers its CONFIDENCE virus clearance services to support validation of viral clearance processes.