{"product_id":"gmp-quality-agreements","title":"GMP Quality Agreements","description":"\u003cp\u003e\u003cstrong\u003eA ready-to-use process for negotiating, approving, and maintaining Quality Agreements with your GMP and GDP vendors\u003c\/strong\u003e — plus two detailed appendices covering exactly what belongs in a strong agreement.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eWho it's for:\u003c\/strong\u003e Virtual sponsors negotiating or managing Quality Agreements (QAg\/QTA) with contract manufacturers, laboratories, and distribution vendors.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eWhat's included:\u003c\/strong\u003e\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003eFull procedure for initiating, negotiating, and approving new Quality Agreements\u003c\/li\u003e\n\u003cli\u003eRevision, periodic review (every 3 years), breach, and termination procedures\u003c\/li\u003e\n\u003cli\u003eAppendix 1: Suggested Elements of a Quality Agreement — a comprehensive checklist covering regulatory requirements, audit provisions, production, stability, and materials management\u003c\/li\u003e\n\u003cli\u003eAppendix 2: GMP IT Vendor Quality Agreement elements, including Part 11 \/ Annex 11 compliance requirements\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 ICH Q7 and 21 CFR Part 11 \/ EU Annex 11 requirements for electronic records and signatures.\u003c\/p\u003e","brand":"FDA-SOPs","offers":[{"title":"Default Title","offer_id":52387175235889,"sku":null,"price":3500.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.fda-sops.com\/products\/gmp-quality-agreements","provider":"FDA-SOPs","version":"1.0","type":"link"}