⚖️ SOP for Working Standard Management in QC Laboratory
⚖️ SOP for Working Standard Management in QC Laboratory 1. Introduction Working standards are critical reference materials in the Quality Control (QC) laboratory used for analytical testing of raw materials, in-process materials, and finished products. Proper management of working standards ensures accuracy, reliability, and traceability of test results, and compliance with GMP and regulatory requirements. Example: A mismanaged working standard of an API assay can lead to inaccurate potency results and batch rejection. 2. Purpose To establish a systematic procedure for the receipt, storage, handling, preparation, calibration, usage, and disposal of working standards in the QC laboratory, ensuring accuracy, traceability, and regulatory compliance. 3. Scope This SOP applies to all working standards, including primary and secondary standards, used in analytical testing of raw materials, in-process samples, and finished products within the QC l...