Add all seven QMS SOP Templates to your cart and automatically unlock a 20% bundle purchase discount. Effective investigation processes are essential to identify root causes, assess product impact, implement corrective and preventive actions (CAPA), and ensure ongoing compliance with current Good Manufacturing Practices (cGMP) as required by global regulatory authorities, including the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. This Standard Operating Procedure (SOP) includes a template to help the user outline the systematic approach to conducting investigations related to deviations, non-conformances, out-of-specification (OOS) results, product complaints, and other quality-related events within a pharmaceutical company’s operations. An editable version of this SOP is included in the E-Reader (under Materials/Supplements) as a downloadable Microsoft® Word® file to purchasers. See the FAQ for accessing instructions.