QA012: SOP FOR SUPPLIER QUALIFICATION
OBJECTIVE: To define a risk-based, documented process to evaluate, qualify, approve, and periodically re-qualify suppliers of materials and services so they consistently meet specifications and GMP requirements. SCOPE: Applies to APIs, Excipients, Primary/printed/secondary packaging, Process aids, Lab chemicals, Contract testing, Calibration and HVAC Validation Contract Manufacturing organizations, Distributors Service agreements for Equipment / Instrument in […]