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© 2021 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2021 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
January 26, 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.
September 02, 2020
Processes, people, and tools are needed to comply with the pharmacopoeia and approved drug product registrations.
July 16, 2020
The Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has issued its final opinion on measures for companies to take that will limit the presence of nitrosamines in human medicines.
May 06, 2020
EMA's Committee for Medicinal Products for Human Use has recommended that all ranitidine medicines be suspended within the European Union as a result of the presence of low levels of NDMA.
May 02, 2020
Industry must never become complacent about the safety of drug products and should seek to continually perform surveillance even if the drug is well-established.
Discovery of carcinogenic nitrosamines in three of the world’s most widely prescribed drugs is driving efforts to better detect, control and prevent their generation in APIs and finished drug products.