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March 16, 2022
USP is advancing understanding and developing guidance and standards to assist industry in implementing continuous manufacturing.
February 24, 2022
USP is developing mRNA quality guidelines to help companies and regulators bring innovative medicines to market faster.
October 02, 2021
Updates to Ph. Eur. include validated tests for N-nitrosamine impurities in sartan APIs.
Public health challenges have highlighted the need for agility in maintaining the quality of medicines.
March 15, 2021
February 03, 2021
Viewpoint: Continued dialogue among pharma stakeholders is needed to achieve consensus regarding excipient composition.
December 03, 2020
USP is preparing for 2021 while also supporting the development of vaccines and treatments for COVID-19.
December 02, 2020
The European Pharmacopoeia is preparing for 2021 while also supporting the industry to develop vaccines and treatments for COVID-19.
November 18, 2020
EDQM announced three new Official Control Authority Batch Release guidelines that describe the tests to be performed by Official Medicines Control Laboratories in the European Union OCABR Network.
October 15, 2020
Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.