OR WAIT null SECS
The digital transformation of quality-by-design assessment workflows can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.
The authors discuss subjectivity in the ICH Q9 (R1) guidance document.
Understanding how to apply phase-appropriate GMPs is crucial for achieving successful regulatory approval.
October 18, 2024
The agency’s CHMP recommended drugs to treatments for hemophilia, two biosimilars for psoriasis, and two flu vaccines at their October meeting.
October 11, 2024
The draft joint network strategy for the EU until 2028 will be open for public consultation until Nov. 30, 2024.
Aseptic fill/finish of biopharmaceuticals requires an understanding of the structure and limitations of each molecule.
In this article, the authors explored the elimination of a water rinse and blow down following the caustic wash step, examining potential safety considerations, the effect on the quality of the cleaning process, and the potential benefit of implementing this change.
This year's CPHI award winners emphasize achievements in pharma excellence.
October 10, 2024
At CPHI Milan, Zaim Gashi, area sales manager of Steriline, discussed the evolution of aseptic processing equipment to stay compliant with current regulations.
October 04, 2024
The agency is working with the European medicines regulatory network to improve the assessment and approval process for new medications.
Contract organizations offer assistance for testing raw materials obtained from outside suppliers.
October 02, 2024
There is potential to effectively marry the best aspects of mRNA as a modality, to other existing or nascent exciting platforms, such as gene editing.
Substituting a compendial-grade material with a food-grade material is not acceptable, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.