{"product_id":"quality-policy-gmp-virtual-sponsor-of-clinical-program","title":"Quality Policy (GMP) - Virtual Sponsor of Clinical Program","description":"\u003cp\u003e\u003cstrong\u003eA top-level Quality Policy that defines your virtual company's Quality Management System (QMS)\u003c\/strong\u003e - the master document that ties together your GMP, GDP, GCP, GLP, and GVP procedures.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eWho it's for:\u003c\/strong\u003e Virtual pharmaceutical companies engaged in development and commercialization of human drugs, using contract manufacturers, laboratories, packagers, and distribution providers.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eWhat's included:\u003c\/strong\u003e\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003ePurpose and Scope of the Quality Management System\u003c\/li\u003e\n\u003cli\u003eResponsibilities across Senior Management, the Quality Unit, and All Employees\u003c\/li\u003e\n\u003cli\u003eQMS Documentation overview, referencing your SOP on SOPs, Data Integrity, Good Documentation Practices, and Training SOPs\u003c\/li\u003e\n\u003cli\u003eVendor Management and Batch Release overview, including Quality Agreements and CMO\/CRO oversight\u003c\/li\u003e\n\u003cli\u003eDefinitions and Abbreviations (ALCOA+, CMO, CRO, Quality Agreement, GXP)\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 Built around ALCOA+ principles and covering GCP, GDP, GLP, GMP, and GVP requirements.\u003c\/p\u003e","brand":"FDA-SOPs","offers":[{"title":"Default Title","offer_id":52387076342065,"sku":null,"price":3500.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.fda-sops.com\/products\/quality-policy-gmp-virtual-sponsor-of-clinical-program","provider":"FDA-SOPs","version":"1.0","type":"link"}