After a long wait for the new elemental impurities guidelines, the bio/pharma industry must now look ahead to implementation and take action. After a long wait for the new elemental impurities ...

All aspects of a drug’s lifecycle should be considered when evaluating risk assessment for elemental impurities. The safety of a drug product is as important as its effectiveness. Testing a drug for ...

The US Pharmacopeia (USP), a standards-setting body for the content of medicines, has released two new standards to limit the presence of elemental impurities in medicinal products. The standards, &lt ...

The FDA requires drug manufacturers to comply with the standards for elemental impurities. These impurities cover those that are added to the product during the process of manufacturing or those that ...

Dr. Reddy’s, which already has three plants targeted in a warning letter by the FDA, is now recalling products manufactured at another. According to the most recent FDA Enforcement Report, the Indian ...

The mission of the International Council for Harmonisation of Technical needs for prescription drugs for Human Use (ICH) is to make sure safe, effective, and high-quality medicines area units are ...

Smokers looking for Pfizer's cessation med Chantix may have a tough time finding the drug as the pharma giant has halted global distribution on impurity concerns. After finding unacceptable levels of ...

The International Conference on Harmonization (ICH), an international pharmaceutical regulatory harmonization body, has announced the release of a new quality manufacturing guideline for consultation ...

PyroGenesis Canada Inc., the world leader in the design, development, manufacture and commercialization of advanced plasma processes; INRS - ETE, (Institut National de la Recherche Scientifique, Eau ...

Drug makers have been cautioned against having carcinogenic or cancer-causing nitrosamine impurities in their products beyond the permissible limit. It’s learnt, Vidarbha has some of the around 40 ...