The control of impurities in Pharmaceutical Products can be daunting. Impurities, degradants, genotoxic impurities, residual solvents, elemental impurities — the requirements keep changing, and it can be challenging to keep up with the changes and make sure you are in compliance. Just recently, the USP published new General Chapters <476> and <1086> on Impurities in Drug Substances and Drug Products, ICH issued a new guideline M7 on Genotoxic Impurities (now being referred to as DNA Reactive or Mutagenic Impurities), USP has an Expert Panel working on updating the General Chapter on Residual Solvents, and ICH and USP have proposed conflicting requirements for Elemental Impurities.
No wonder it’s challenging keeping up with compliance expectations! As a result of the complexity, many companies choose to react in an overly conservative manner, and end up spending much more money and resources then they really need to. You need to be able to interpret the guidances and understand what the Regulators require, so that you can minimize resource expenditures while maintaining compliance. There are definitely strategies that can help you accomplish this.
If you want to make sure your understanding of the Guidances on Impurities are up to date, and also to learn strategies to save time and money but still be in compliance, plan to attend the one day course, “Control of Impurities in Pharmaceutical Products: Impurities, Degradants, Residual Solvents & Elemental Impurities” on June 18, 2014 in North Brunswick, NJ