Analyst Qualification in Quality Control Laboratories
STANDARD OPERATING PROCEDURE (SOP) Analyst Qualification in Quality Control Laboratories SOP No. QC/SOP/___ Effective Date ___ Revision No. 00 Department Quality Control 1. Purpose To define a comprehensive and step-by-step procedure for qualification, authorization, and requalification of analysts working in the Quality Control laboratory, ensuring accuracy, reproducibility, data integrity, and compliance with GMP, WHO, FDA, EU-GMP, and ICH Q2 requirements. 2. Scope This SOP applies to all analysts performing chemical and instrumental analysis in the Quality Control laboratory, including new employees, experienced analysts, reassigned staff, and contract personnel. 3. Responsibilities QC Head: Final approval of analyst qualification and authorization. QC Manager / Supervisor: Planning, execution, assessment, and recommendation. Analyst: Compliance with SOPs, training, and qualification activities. Quality Assuranc...