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Category Archives: ICH

ICH Q12 is here. What Does it Mean for Pharma?

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…

Posted in APIs, ICH, Neuland Labs, Quality, regulatory | Tagged , , | Comments Off on ICH Q12 is here. What Does it Mean for Pharma?

Green Chemistry and Benign by Design

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…

Posted in analytical science, API synthesis, APIs, atom economy, Benign-by-Design, Capabilities, Chemistry, CMC, Contract Manufacturing, EHS, energy conservation, energy effciency, green chemistry, ICH, Impurity profile, Quality, R&D, Route Design, Route Scouting, small molecule, synthesis, Synthesis Route, Uncategorized, zero liquid discharge | Comments Off on Green Chemistry and Benign by Design

API Production: Building an Impurity Profile

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…

Posted in analytical science, API synthesis, APIs, Chemistry, CMC, Contract Manufacturing, CRO/CMO, ICH, Impurity profile, method development, Quality, regulatory | Comments Off on API Production: Building an Impurity Profile

APIs, Quality Agreements and the Partner-or-Supplier Debate.

It’s been nearly two years since the FDA issued their draft guidance on quality agreements and contract manufacturer management.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…

Posted in agreement, APIs, change orders, Contract Manufacturing, CRO/CMO, FDA, ICH, method development, Project Management, Quality Agreement | Comments Off on APIs, Quality Agreements and the Partner-or-Supplier Debate.