Multilingual support available in English, Simplified Chinese. NO SOFTWARE SYSTEM INCLUDED
2026 Version Update: – 69 Professional SOPs – 13 Modules with Manuals – 300+ Document for Plugins – cGMP & cGTP Compliance – Monitor by real Professionals
The HCCT Master Package is a complete, production-ready quality documentation system built from the ground up to satisfy the full scope of FDA drug cGMP (21 CFR Parts 210 & 211), current Good Tissue Practice (21 CFR Part 1271), electronic records requirements (21 CFR Part 11), and international quality management principles (ICH Q9 & Q10).
This is not a collection of generic templates. Every SOP in this package has been structured with real-world inspection readiness in mind — complete with implementation notes highlighting typical FDA inspection focal points, embedded checklists for common pitfalls, and placeholder fields that you adapt to your own facility, products, and organizational structure.
The 2026 Edition delivers 69 fully-developed SOP documents, a comprehensive Core Compliance Manual, and a Master Document Index — totaling 300+ sub-documents including forms, logs, checklists, report templates, and approval records. All documents are provided in editable Microsoft Word (.docx) format with bilingual content (English / 中文) throughout.
Who this package is for:
• HCT/P & Cell Therapy Manufacturers — Tissue banks, cell processing labs, and exosome production facilities preparing for FDA establishment registration or pre-approval inspection.
• Small & Mid-Size Enterprises (SMEs) — Companies that need a complete FDA-aligned cGMP system but do not yet have a full in-house QA team to write everything from scratch.
• QA Managers & Quality Professionals — Experienced QA managers who want a consistent, proven template set to deploy across new sites, product lines, or tech-transfer projects.
• CDMOs & Contract Facilities — Contract development and manufacturing organizations that need a standardized quality framework to onboard new clients and demonstrate cGMP readiness.
• Clinics & Research Labs Transitioning to GMP — Academic or clinical labs moving from research-grade operations to FDA-regulated manufacturing, needing a structured compliance roadmap.
• Consultants & Regulatory Advisors — Quality consultants who advise multiple clients and need a comprehensive, white-label-ready documentation foundation.
What’s included 1. FDA cGMP Complete Compliance Framework (Core Manual) A comprehensive master document (~50+ pages) covering the entire quality management system: quality policy, organizational structure, documentation hierarchy, production controls, HCT/P-specific requirements, validation, deviation/CAPA, training, audit readiness, risk management, and data integrity. Serves as the “backbone” document for your entire site QA system. (核心手册 — 完整合规框架)
2. Master Document Index A complete catalog of all 69 SOPs with bilingual listings, module mapping, regulatory cross-reference matrix, document hierarchy guide, implementation roadmap, and maintenance schedule. (总文件索引)
3. 69 Professional SOP Documents across 13 Modules Each SOP includes: Document Control Header (Doc No., Rev, Prepared/Reviewed/Approved By), Revision History, Table of Contents, 8 Standard Sections (Purpose, Scope, Responsibilities, Definitions, Procedure, Documentation & Records, References, Training Requirements), detailed tables and matrices, implementation notes with inspection focal points, forms/checklists in appendices, and approval signature block. All bilingual English/Chinese. (69份专业SOP文件，涵盖13个模块)
FDA cGMP Complete Compliance Framework (Core Manual) A structured overview of the full cGMP system, covering quality management, documentation, production, facilities, equipment, materials, validation, deviations/CAPA, and internal audits. Ideal as the “master document” for your site QA system.
Ready‑to‑Adapt QA SOPs (DOCX) Each SOP is delivered as an editable Word file with purpose, scope, responsibilities, and step‑by‑step procedures, so your team can customize and implement quickly.
The foundation of your quality system. Covers the Quality Manual, gap analysis, document control, deviation/CAPA, change control, audits, training, supplier qualification, equipment qualification, process validation, data integrity, annual product review, and records management.
• QP-SOP-001: QMS Quality Program / Pharmaceutical Quality System (Quality Manual) • QA-SOP-000: GMP-GTP Requirements Mapping & Gap Analysis • QA-SOP-001: Quality Management System & QA Responsibilities • QA-SOP-002: Document & Record Control • QA-SOP-003: Deviation, Investigation & CAPA Management • QA-SOP-004: Change Control Procedure • QA-SOP-005: Internal Audit & Inspection Readiness • QA-SOP-006: Training, Qualification & Competency Management • QA-SOP-007: Supplier Qualification & Material Release • QA-SOP-008: Equipment Qualification, Calibration & Maintenance • QA-SOP-010: Process Validation & Ongoing Process Verification • QA-SOP-011: Data Integrity & Electronic Records Oversight • QA-SOP-012: Product Quality Review / Annual Product Review & Trending (APQR/PQR) • QA-SOP-013: GMP Records & Reports Management
The largest module. Covers HCT/P tissue procurement, aseptic processing, batch records, line clearance, sampling, packaging, rework, hold times, exosome product control strategy, and HCT/P-specific change control.
• HCT-SOP-001: HCT/P Recovery — Tissue/Cell Procurement, Labeling & Transport (361/351 HCT/P) • HCT-SOP-002: HCT/P Processing — Aseptic Handling, Hold Times & In-Process Controls • PRD-SOP-001: Batch Manufacturing & Packaging Record Management • PRD-SOP-002: Line Clearance & Status Labelling • PRD-SOP-003: Sampling, In-Process Controls & Yield Reconciliation • PRD-SOP-004: Packaging & Labelling Control • PRD-SOP-005: Reworking / Reprocessing & Repackaging • PRD-SOP-006: Batch Record Review & Production Documentation • PRD-SOP-007: Intermediate and Bulk Hold Time Management • PRD-QC-CTL-001: MSC Exosome Product Control Strategy • CHG-SOP-001: HCT/P & Process Change Control
Module 05 — Equipment / 设备 (2 Documents)
• EQP-SOP-002: Equipment Cleaning, Setup & Line Changeover • EQP-SOP-003: Cleaning, Use Log and Cleaning Validation
Module 06— Facilities / 设施 (2 Documents)
• FAC-SOP-001: Cleaning & Sanitation of Production and Storage Areas • FAC-SOP-002: Environmental Monitoring & Room Classification
Module 07 — Utilities / 公用系统 (2 Documents)
• UTL-SOP-001: Water System Operation, Monitoring & Sanitization • UTL-SOP-002: HVAC Operation, Filter Management & Alarm Handling
Module 08 — Quality Control Laboratory / 质量控制实验室 (5 Documents)
• QRM-SOP-001: Quality Risk Management (QRM) Process
< Practical implementation notes > Embedded comments and checklists in the documents to highlight typical inspection focus points, common pitfalls, and fields you must adapt to your own organization before usage.
Format – More than 300+ Sub-Documents Structure for reporting – All files in .docx format for easy editing – Structured headings for quick import into your own QMS / DMS
