Add all seven QMS SOP Templates to your cart and automatically unlock a 20% bundle purchase discount. This Standard Operating Procedure (SOP) template provides a structured approach for the identification, investigation, evaluation, and resolution of Out-of-Specification (OOS) results observed during pharmaceutical manufacturing and testing. The objective is to ensure that all OOS results, whether from in-process testing, finished product testing, raw materials, or in-process samples, are addressed in a scientifically sound, compliant, and timely manner while upholding regulatory requirements and promoting product quality and patient safety. 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.