Blood Glucose Test Strip Production Standard Operating Procedures (SOP Collection)¶
This folder contains structured SOPs, work instructions, quality specifications, and templates for glucose test strip production.
Environment Classifications¶
- Material Preparation Room: ISO-9
- Test Strips Production Site: ISO-7, Humidity <20%
- Packing Room: Controlled
| No. | Document | Purpose | Version |
|---|---|---|---|
| 01 | 01-equipment-list.md | Equipment Master List | v1.0 |
| 02 | 02-process-flow-overview.md | High-Level Process Flow | v1.0 |
| 03 | 03-material-specifications.md | Material Specs (L1/L2/L3) | v1.0 |
| 04 | 04-enzyme-solution-preparation.md | Enzyme Solution Preparation | v1.0 |
| 05 | 05-line1-enzyme-dispense-dry-inspection.md | Line 1 Work Instruction | v1.0 |
| 06 | 06-line2-lamination-punch-row-cut.md | Line 2 Work Instruction | v1.0 |
| 07 | 07-line3-slitting-vial-capping.md | Line 3 Work Instruction | v1.0 |
| 08 | 08-line4-packaging.md | Line 4 Packaging Work Instruction | v1.0 |
| 09 | 09-quality-inspection-standard.md | Quality Standards | v1.0 |
| 10 | 10-product-work-instruction.md | Consolidated Work Instruction | v1.0 |
| 11 | 11-quality-test-report-template.md | QC Test Report Template | v1.0 |
| 12 | 12-certificate-of-analysis-template.md | Certificate of Analysis | v1.0 |
Usage Principles¶
- Maintain version control for all modifications; increment Version in header and record change history.
- Equipment/process changes trigger review and update of related SOPs and inspection specifications.
Revision Control¶
Each SOP follows a standard structure: Purpose / Scope / Responsibilities / Safety / Materials & Equipment / Procedure / Records / Acceptance Criteria.
Future Extensions¶
- EHS (Environment Health Safety) Appendix
- FMEA (Failure Mode Effects Analysis)
- Risk Register
Version: v1.0 | Language: English (en)