EAS pharma expert, Joe McGuinness, published an article in Tablets and Capsules on coming to terms with the requirement of GMP implementation. While GMPs have always been required (in theory) for Active Pharmaceutical Ingredients (APIs), the FDA often found itself at odds with this industry as it tried to make the case for GMP controls. With the publication of the ICH Q7 Guidance in 1996, true alignment began. Even over the last ten years, GMPs have been emphasized in compounding pharmacies given their increased scrutiny by FDA. GMPs can seem “new” in cases such as these. (Even the “current” aspect of a GMP principle can seem like the introduction of a totally new requirement to an organization as it struggles to regain its knowledge and comfort base.) As organizations change over time, changes to the Quality System or the addition of new businesses drivers bring an emphasis to areas of GMPs not needed before. Thus, an organization may go through the stages of “GMP grief” many times in their lifetime.
Posted in Drugs, EAS in Action.