
The International Council for Harmonisation (ICH) is an organization which brings together the pharmaceutical industry and regulatory authorities to improve the synchronization of industry regulations. The organization’s ultimate goal is…
7 ways to boost profits and reduce pharma synthesis waste At Neuland, we’re advocates of green chemistry. Not only is it better for the environment, but it’s also just logistically…
Impurities and the ICH Limits for Impurities Impurities are unwanted chemicals produced during normal manufacturing of Active Pharmaceutical Ingredients, or APIs. As you well know, impurities have no therapeutic value…
It’s been nearly two years since the FDA issued their draft guidance on quality agreements and contract manufacturer management. The consensus seems to be that the FDA shifted the responsibility…