QC (Quality Control) chemical testing ensures raw materials, intermediates, and finished products meet defined specifications. Adherence to Good Testing Procedures is essential for accurate, reliable, and compliant results.
Below are the core principles and practices of GTP in QC chemical laboratories:
✅ 1. Clear Purpose and Scope
- Define what is being tested (e.g., assay, identification, impurities, pH).
- State why the test is performed (release, stability, in-process).
- Reference applicable standards (USP, EP, BP, internal specs).
🧪 2. Use Validated and Approved Methods
- Follow validated analytical methods or pharmacopoeial procedures.
- Confirm method suitability, including:
- Accuracy
- Precision
- Specificity
- Linearity
- Robustness
- Keep controlled copies of test procedures.
📦 3. Sample Management
- Use representative sampling plans.
- Label samples clearly with:
- Batch/Lot number
- Test reference
- Date and time of sampling
- Ensure proper storage conditions to maintain integrity.
⚙️ 4. Equipment Qualification and Calibration
- Use only:
- Qualified instruments (IQ/OQ/PQ completed)
- Calibrated balances, pipettes, pH meters, HPLC, etc.
- Check calibration status labels before use.
- Record instrument ID in test records.
🧴 5. Reagents and Standards Handling
- Use approved reagents and certified reference standards.
- Verify:
- Expiry date
- Proper storage conditions
- Labeling and documentation
- Prepare and label solutions with:
- Preparation date
- Expiry date
- Prepared by and verified by signatures
✋ 6. Good Laboratory Practices (GLP)
- Maintain:
- Clean and organized workspaces
- Proper gowning and hygiene
- Segregation of areas (e.g., weighing, sample prep, analysis)
- Avoid cross-contamination.
🔍 7. Control Measures
- Run required controls:
- Blank solutions
- System suitability tests
- Standard solutions / calibration curves
- Document acceptance criteria and results.
📝 8. Accurate Documentation
- Record all observations and data contemporaneously:
- Raw data entries
- Instrument printouts
- Calculations
- Follow Good Documentation Practices (GDP):
- No overwriting
- Correct errors with a single line and signature
- Complete, legible records
⏳ 9. Data Review and Approval
- Perform independent verification of:
- Raw data
- Calculations
- Result transcriptions
- Review and approve records by authorized personnel before release.
⚠️ 10. Deviation and OOS Handling
- Immediately document and investigate:
- Deviations from procedures
- Out-of-specification (OOS) results
- Follow approved investigation procedures.
- Implement corrective actions as needed.
🗑️ 11. Waste Disposal
- Dispose of:
- Chemical waste
- Solvents
- Contaminated consumables
according to hazardous waste management procedures.
🌟 Summary
Good Testing Procedure in QC Chemical Testing means using validated methods, qualified equipment, verified standards, and robust documentation to generate reliable, traceable, and compliant results.
- Arsenic test BP
- Benzethonium Chloride 0.004 M
- Ceric Ammonium Sulphate 0.1 M
- Clarity of Solution BP
- Colour of Solution BP
- Description Test IH
- Disodium Edetate 0.1 M
- Heavy Metal Test BP
- Hydrochloric Acid 0.1 M
- Hydrochloric Acid 0.05 M
- Hydrochloric Acid 1 M
- Iodine 0.1 M
- Iodine 0.05 M
- Loss on Drying BP
- Perchloric Acid 0.1 M
- Polymorphism BP
- Potassium Hydroxide 0.1 M
- Silver Nitrate 0.1 M
- Silver Nitrate 0.05 M
- Sodium Edetate 0.1 M
- Sodium Hydroxide 0.1 M
- Sodium Hydroxide 0.05 M
- Sodium Hydroxide 1.0 M
- Sodium Nitrate 0.1 M
- Sodium Thiosulphate 0.1 M
- Solubility BP
- Sulphated Ash BP
- Determination of Water BP
- Zinc Sulfate 0.1 M