{"product_id":"gmp-vendor-audits","title":"GMP Vendor Audits","description":"\u003cp\u003e\u003cstrong\u003eA complete GMP vendor audit program\u003c\/strong\u003e — covering audit planning, on-site and virtual audit execution, finding classification, and closure, built for sponsors managing outsourced manufacturing and testing.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eWho it's for:\u003c\/strong\u003e Virtual sponsors responsible for auditing CMOs, CROs, and other GMP vendors, with or without an internal audit team.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eWhat's included:\u003c\/strong\u003e\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003eAnnual Audit Plan development and audit frequency requirements (minimum every 3 years)\u003c\/li\u003e\n\u003cli\u003eFull audit procedure: preparation, opening meeting, on-site\/virtual execution, and close-out meeting\u003c\/li\u003e\n\u003cli\u003eFinding classification system (Critical, Major, Minor) and CAPA follow-up expectations\u003c\/li\u003e\n\u003cli\u003eAudit reporting requirements and required report elements\u003c\/li\u003e\n\u003cli\u003eAudit closure and tracking procedures\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cstrong\u003eFormat:\u003c\/strong\u003e Fully editable Word document (.docx).\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eRegulatory alignment:\u003c\/strong\u003e References FDA 21 CFR Parts 210 and 211.\u003c\/p\u003e","brand":"FDA-SOPs","offers":[{"title":"Default Title","offer_id":52387170812209,"sku":null,"price":2500.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.fda-sops.com\/products\/gmp-vendor-audits","provider":"FDA-SOPs","version":"1.0","type":"link"}