{"title":"SOPs","description":"\u003cp\u003eFull Set of SOPs \u003c\/p\u003e","products":[{"product_id":"training-sop","title":"Training SOP - FREE SAMPLE SOP","description":"\u003cp\u003e\u003cstrong\u003eOur free sample SOP\u003c\/strong\u003e - see exactly the format, depth, and quality of every FDA-SOPs document before you buy. This is a complete, ready-to-use Training Program SOP for virtual pharmaceutical sponsors.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWho it's for:\u003c\/strong\u003e Virtual sponsors that need a complete process for documenting employee and contractor GXP training, no in-house QA department required.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWhat's included:\u003c\/strong\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eTraining plan management (Master Training Plan, department-level reviews)\u003c\/li\u003e\n\u003cli\u003e12 governing Standards covering contractor qualification, required documentation, and annual curricula reviews\u003c\/li\u003e\n\u003cli\u003eFull procedure for completing Read-and-Understand and Interactive training records\u003c\/li\u003e\n\u003cli\u003eAssociated training record forms (QA003F1, QA003F2) referenced throughout\u003c\/li\u003e\n\u003cli\u003eAnnual GXP training planning process\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cstrong\u003eFormat:\u003c\/strong\u003e Fully editable Word document (.docx), 5 pages - free to download, no strings attached.\u003c\/p\u003e","brand":"FDA-SOPs","offers":[{"title":"Default Title","offer_id":45087472484657,"sku":"","price":0.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0749\/9812\/0753\/files\/training-cover.png?v=1790021338"},{"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\n\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\n\u003cp\u003e\u003cstrong\u003eWhat's included:\u003c\/strong\u003e\u003c\/p\u003e\n\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\n\u003cp\u003e\u003cstrong\u003eFormat:\u003c\/strong\u003e Fully editable Word document (.docx), 5 pages.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eRegulatory alignment:\u003c\/strong\u003e Built around ALCOA+ principles and covering GCP, GDP, GLP, GMP, and GVP requirements.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eRefund policy:\u003c\/strong\u003e All sales are final. Because you receive the complete, editable Word file immediately upon purchase, we're unable to offer refunds once the file has been delivered.\u003c\/p\u003e","brand":"FDA-SOPs","offers":[{"title":"Default Title","offer_id":52387076342065,"sku":null,"price":1400.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0749\/9812\/0753\/files\/quality-policy-cover.png?v=1790021316"},{"product_id":"data-integrity","title":"Data Integrity","description":"\u003cp\u003e\u003cstrong\u003eA complete, audit-ready Data Integrity and Record Retention Policy for GXP documentation\u003c\/strong\u003e — built around the ALCOA+ framework and covering GCP, GDP, GLP, GMP, and GVP requirements.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWho it's for:\u003c\/strong\u003e Virtual and lean pharmaceutical sponsors responsible for creating or maintaining GXP documentation governed by Health Authorities.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWhat's included:\u003c\/strong\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003ePurpose and Scope\u003c\/li\u003e\n\u003cli\u003eResponsibilities and Approvals (department sign-off table)\u003c\/li\u003e\n\u003cli\u003eAssociated Documents and References — pairs with our Good Documentation Practices SOP (QA004)\u003c\/li\u003e\n\u003cli\u003eDefinitions and Abbreviations (ALCOA+, GXP, electronic vs. physical records, and more)\u003c\/li\u003e\n\u003cli\u003e11 governing Principles covering data integrity controls, risk-based data criticality, access control, and archival requirements\u003c\/li\u003e\n\u003cli\u003eAppendices section (template — add your company-specific forms)\u003c\/li\u003e\n\u003cli\u003eVersion History log\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cstrong\u003eFormat:\u003c\/strong\u003e Fully editable Word document (.docx), 3 pages.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eRegulatory alignment:\u003c\/strong\u003e ALCOA+ (Attributable, Legible, Contemporaneous, Original or Certified Copy, Accurate, Complete, Consistent, Enduring, Available); applicable across GCP, GDP, GLP, GMP, and GVP.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eRefund policy:\u003c\/strong\u003e All sales are final. Because you receive the complete, editable Word file immediately upon purchase, we're unable to offer refunds once the file has been delivered.\u003c\/p\u003e","brand":"QualitySOPs","offers":[{"title":"Default Title","offer_id":52387090497841,"sku":null,"price":1200.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0749\/9812\/0753\/files\/data-integrity-cover.png?v=1790021296"},{"product_id":"sop-on-sops","title":"SOP on SOPs","description":"\u003cp\u003e\u003cstrong\u003eThe foundational SOP that governs how all your other SOPs, Policies, Manuals, and Forms are created, numbered, reviewed, and maintained\u003c\/strong\u003e - the document control backbone of your Quality Management System.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWho it's for:\u003c\/strong\u003e Virtual pharmaceutical sponsors setting up or standardizing their document control system across Policies, SOPs, Manuals, and Forms.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWhat's included:\u003c\/strong\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eDocument hierarchy (Manuals, Policies, SOPs, Forms) and numbering conventions\u003c\/li\u003e\n\u003cli\u003e16 governing Standards covering document ownership, review cycles, approval signatures, and periodic review timing\u003c\/li\u003e\n\u003cli\u003eFull procedure for creating, revising, and obsoleting documents, plus the review and approval workflow and periodic review process\u003c\/li\u003e\n\u003cli\u003eAppendix 1: Required Elements - header\/footer requirements and required sections by document type, in detailed reference tables\u003c\/li\u003e\n\u003cli\u003eAppendix 2: Document Numbering and Designations (department alpha codes, numbering scheme)\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cstrong\u003eFormat:\u003c\/strong\u003e Fully editable Word document (.docx), 10 pages.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eRegulatory alignment:\u003c\/strong\u003e References 21 CFR 211.22 (Responsibilities of the Quality Control Unit).\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eRefund policy:\u003c\/strong\u003e All sales are final. Because you receive the complete, editable Word file immediately upon purchase, we're unable to offer refunds once the file has been delivered.\u003c\/p\u003e","brand":"FDA-SOPs","offers":[{"title":"Default Title","offer_id":52387113140529,"sku":null,"price":1300.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0749\/9812\/0753\/files\/sop-on-sops-cover.png?v=1790021274"},{"product_id":"good-documentation-practices","title":"Good Documentation Practices","description":"\u003cp\u003e\u003cstrong\u003eThe detailed, practical companion to your Data Integrity Policy\u003c\/strong\u003e — exact rules for how GXP documentation should be written, corrected, signed, and retained, down to date formats and correction procedures.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWho it's for:\u003c\/strong\u003e All personnel — employees, contractors, consultants — who create, review, approve, or maintain GXP documentation.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWhat's included:\u003c\/strong\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eALCOA+ documentation standards: date\/time formatting, decimal and rounding rules, signature requirements\u003c\/li\u003e\n\u003cli\u003e16-step General Requirements procedure covering everything from ink color to Table of Contents requirements\u003c\/li\u003e\n\u003cli\u003eCorrection procedures for physical and electronic records, including omitted-entry documentation\u003c\/li\u003e\n\u003cli\u003eCertified Copy creation process\u003c\/li\u003e\n\u003cli\u003eElectronic Signature Attestation Form (QA004F1)\u003c\/li\u003e\n\u003cli\u003eFull Definitions glossary (ALCOA+, Metadata, Raw Data, Static\/Dynamic Data, and more)\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cstrong\u003eFormat:\u003c\/strong\u003e Fully editable Word document (.docx), 7 pages.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eRegulatory alignment:\u003c\/strong\u003e Cites FDA retention requirements under 21 CFR §§ 211.68(b), 211.188, 211.194, and 212.60.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eRefund policy:\u003c\/strong\u003e All sales are final. Because you receive the complete, editable Word file immediately upon purchase, we're unable to offer refunds once the file has been delivered.\u003c\/p\u003e","brand":"QualitySOPs","offers":[{"title":"Default Title","offer_id":52387132014897,"sku":null,"price":1200.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0749\/9812\/0753\/files\/good-doc-practices-cover_1eb9d3a0-7dd0-4500-b6e6-64afc5c28f0a.png?v=1790021254"},{"product_id":"gmp-vendor-management","title":"GMP Vendor Management","description":"\u003cp\u003e\u003cstrong\u003eA complete vendor qualification and management system for virtual sponsors\u003c\/strong\u003e relying on CMOs, CROs, and other GMP service providers — from initial selection through ongoing periodic assessment.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWho it's for:\u003c\/strong\u003e Virtual sponsors managing GMP vendors without an internal vendor management team.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWhat's included:\u003c\/strong\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eVendor status classification system (Approved-Qualified, Conditionally Approved, Retired, and more)\u003c\/li\u003e\n\u003cli\u003eFull vendor selection and qualification procedure, including the Quality Survey process form (QA010F1)\u003c\/li\u003e\n\u003cli\u003eVendor status change and termination procedures\u003c\/li\u003e\n\u003cli\u003eAnnual periodic assessment scheme, including audit frequency and performance review\u003c\/li\u003e\n\u003cli\u003eDocument archiving requirements\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cstrong\u003eFormat:\u003c\/strong\u003e Fully editable Word document (.docx), 6 pages.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eRefund policy:\u003c\/strong\u003e All sales are final. Because you receive the complete, editable Word file immediately upon purchase, we're unable to offer refunds once the file has been delivered.\u003c\/p\u003e","brand":"QualitySOPs","offers":[{"title":"Default Title","offer_id":52387166617905,"sku":null,"price":1300.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0749\/9812\/0753\/files\/vendor-management-cover.png?v=1790021212"},{"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\n\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\n\u003cp\u003e\u003cstrong\u003eWhat's included:\u003c\/strong\u003e\u003c\/p\u003e\n\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\n\u003cp\u003e\u003cstrong\u003eFormat:\u003c\/strong\u003e Fully editable Word document (.docx), 7 pages.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eRegulatory alignment:\u003c\/strong\u003e References FDA 21 CFR Parts 210 and 211.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eRefund policy:\u003c\/strong\u003e All sales are final. Because you receive the complete, editable Word file immediately upon purchase, we're unable to offer refunds once the file has been delivered.\u003c\/p\u003e","brand":"QualitySOPs","offers":[{"title":"Default Title","offer_id":52387170812209,"sku":null,"price":1200.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0749\/9812\/0753\/files\/vendor-audits-cover.png?v=1790021173"},{"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\n\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\n\u003cp\u003e\u003cstrong\u003eWhat's included:\u003c\/strong\u003e\u003c\/p\u003e\n\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\n\u003cp\u003e\u003cstrong\u003eFormat:\u003c\/strong\u003e Fully editable Word document (.docx), 8 pages.\u003c\/p\u003e\n\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\n\u003cp\u003e\u003cstrong\u003eRefund policy:\u003c\/strong\u003e All sales are final. Because you receive the complete, editable Word file immediately upon purchase, we're unable to offer refunds once the file has been delivered.\u003c\/p\u003e","brand":"QualitySOPs","offers":[{"title":"Default Title","offer_id":52387175235889,"sku":null,"price":1500.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0749\/9812\/0753\/files\/quality-agreements-cover.png?v=1790021152"},{"product_id":"gmp-batch-review-and-release","title":"GMP Batch Review and Release","description":"\u003cp\u003e\u003cstrong\u003eDefines your company's batch review and release process for vendor-manufactured drug product\u003c\/strong\u003e — including a risk-based Reduced Review scheme so you're not doing full record review on every batch once a vendor has a track record.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWho it's for:\u003c\/strong\u003e Virtual sponsors releasing drug product manufactured by contract manufacturers, where release authority stays with the sponsor rather than the vendor.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWhat's included:\u003c\/strong\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eFull batch review and release procedure (batch records, Certificate of Analysis, Certificate of Compliance, deviation investigations, change controls)\u003c\/li\u003e\n\u003cli\u003eVendor qualification pathway to Reduced Review status, based on the first 3 batches reviewed\u003c\/li\u003e\n\u003cli\u003eReduced Review procedure and periodic full-review monitoring scheme, scaled to batch volume\u003c\/li\u003e\n\u003cli\u003eBatch Review and Release Form (QA014F1) referenced throughout\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cstrong\u003eFormat:\u003c\/strong\u003e Fully editable Word document (.docx), 4 pages.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eRefund policy:\u003c\/strong\u003e All sales are final. Because you receive the complete, editable Word file immediately upon purchase, we're unable to offer refunds once the file has been delivered.\u003c\/p\u003e","brand":"QualitySOPs","offers":[{"title":"Default Title","offer_id":52387179987249,"sku":null,"price":1200.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0749\/9812\/0753\/files\/batch-review-cover.png?v=1790021119"}],"url":"https:\/\/qualitysops.com\/collections\/sops.oembed","provider":"QualitySOPs","version":"1.0","type":"link"}