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Qa QC Test Strips

This SOP details the quality assurance and control procedures for the production of various diagnostic test strips, ensuring compliance with ISO and GMP standards. It outlines responsibilities, production processes, in-process testing, equipment maintenance, environmental monitoring, final product testing, documentation, deviation handling, and continuous improvement practices. The document emphasizes the importance of supplier control, calibration, and rigorous testing to maintain product quality.

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Mohamed Seleman
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8 views2 pages

Qa QC Test Strips

This SOP details the quality assurance and control procedures for the production of various diagnostic test strips, ensuring compliance with ISO and GMP standards. It outlines responsibilities, production processes, in-process testing, equipment maintenance, environmental monitoring, final product testing, documentation, deviation handling, and continuous improvement practices. The document emphasizes the importance of supplier control, calibration, and rigorous testing to maintain product quality.

Uploaded by

Mohamed Seleman
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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QA/QC SOP for Production of Diagnostic Test Strips (English Version)

1. Purpose and Scope This SOP outlines the quality assurance and quality
control procedures for the production of diagnostic test strips including
glucose, HCG (pregnancy), viral, and bacterial detection strips. It covers all
stages from chemical preparation to final product testing, compliant with ISO
13485, ISO 9001, and GMP standards.
2. Responsibilities - QA Manager: Overall supervision, compliance
verification, documentation review. - Production Supervisor: Ensure SOP
adherence on production floor. - QC Analysts: Conduct in-process and final
product testing. - Lab Technicians: Prepare reagents and perform process
checks.
3. Supplier & Raw Material Control - All strip substrates and base
materials are imported. - Suppliers must provide Certificates of Analysis
(COA). - Incoming chemical reagents are checked for purity, lot number, and
expiration.
4. Production Process Control - Chemical Preparation: Prepare
reagents under controlled temperature and humidity. - Coating Process:
Apply reagents uniformly on strip substrates using calibrated machines. -
Drying & Curing: Use temperature and humidity-controlled ovens; monitor
process parameters. - Cutting & Packaging: Cut strips to size and package
in moisture-proof pouches.
5. In-Process Testing - Strip uniformity: Check reagent deposition
consistency on 10% of batch. - Functional spot tests: Verify color change or
reactivity in test strips. - pH and concentration checks of prepared reagents.
6. Equipment Calibration & Maintenance - All production and testing
equipment calibrated monthly. - Maintain calibration logs and certificates. -
Routine maintenance per manufacturer instructions.
7. Environmental Monitoring - Maintain production area at specified
temperature (20–25°C) and humidity (30–50%). - Weekly microbial
contamination checks. - Cleanroom protocols enforced.
8. Final Product Testing - Glucose Strips: - Sensitivity: 50–500 mg/dL -
Accuracy: ±5% deviation - Repeatability: CV ≤3% - HCG Strips: -
Sensitivity: ≥25 mIU/mL - Accuracy: 95% detection in control samples -
Repeatability: 98% concordance - Viral Strips (COVID-19 Example): -
Limit of detection: 1000 viral particles/mL - Sensitivity: ≥95% - Specificity:
≥98% - Bacterial Strips: - Detection limit: 10^3 CFU/mL - Accuracy: ≥95%
- Reproducibility: 97% concordance
9. Documentation & Record Keeping - Maintain batch records, QC logs,
equipment logs. - Store records digitally and physically for 5 years.
10. Deviation Handling & CAPA - Document all deviations. - Immediate
corrective actions implemented. - Root cause analysis conducted and
preventive measures applied.
11. Internal Audit & Continuous Improvement - Monthly internal audits.
- Review SOP adherence, QC failures, and process efficiency. - Implement
improvements and update SOPs annually.

End of English Version

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