Dietary Supplement cGMP HACCP System Documents Full Pack (FDA 21 CFR Part 111 Quality Manual SOp Batch Record Haccp Plan Audit Checklist )
A complete, audit-ready cGMP and HACCP quality management system for dietary supplement and vitamin manufacturers — built on FDA 21 CFR Part 111 and Codex CXC 1-1969 (2022) HACCP. 71 professionally written documents covering every regulatory requirement, including an FDA Inspection Readiness Guide.
What's Included
- Quality Manual, 27 Procedures, 10 SOPs, and 6 Job Descriptions
- Master Manufacturing Record, Batch Production Record, Stability, and Label Compliance templates
- 295-clause-referenced internal audit checklist
- HACCP Hazard Analysis and CCP log
- Registers, KPI Tracker, Risk Register, Clause Coverage Matrix, and FDA Inspection Readiness Guide
- 51 Word + 20 Excel files | Instant download
Designed For
Supplement and vitamin manufacturers, quality managers, cGMP and HACCP consultants, contract manufacturers, and organizations preparing for an FDA inspection.
Implementation
1. Download 2. Run Find & Replace to customize to your brand 3. Implement. Full clause coverage. Everything in one kit. Fully editable in Microsoft Word & Excel.
Estimated time savings: 100+ hours compared to building documentation from scratch.
Digital templates for you to customize with your own validated values. This is a documentation toolkit, not certification, legal, or regulatory advice. Instant digital download.