OR WAIT null SECS
June 25, 2020
The importance of capability and capacity of a CDMO partner to deliver drug substance and product testing should never be underestimated, considering the increasing complexity of compounds in development.
June 22, 2020
The guidance document provides recommendations for CGMP expectations to prevent contamination of drugs and exclude sick workers from participating in drug manufacturing.
June 19, 2020
The products are being recalled because of missing graduation marks on the dosing cups
June 18, 2020
The European Directorate for the Quality of Medicines and Healthcare (EDQM) has opened up access to the texts of the European Pharmacopoeia (Ph. Eur.) to support developers of COVID-19 vaccines.
June 04, 2020
The company is voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, because of the detection of N-Nitrosodimethylamine.
June 03, 2020
Recent drug recalls in the United States from nitrosamine contamination prompt the need for more sensitive impurity testing methods and a re-evaluation of acceptable lower limit levels.
June 02, 2020
Consider how to assess risks and understand possible sources of disinfectant residues in pharmaceutical manufacturing.
The EU’s pharmaceutical strategy has the potential to shake up the policies and regulations of the region’s medicines sector.
Bioanalytical studies are an important aspect of biologic drug development that may necessitate partnering with bioanalysis experts.
Survey results indicate that the current regulatory approval pathway for excipients creates a challenge for the use of novel excipients.