- Protocol for Instrument Criticality
- Criticality Evaluation of Weighing Balance
- Criticality Evaluation of Water System Device
- Criticality Evaluation of Warehouse Device
- Criticality Evaluation of Utility Instruments and Device
- Criticality Evaluation of QC Instruments
- Criticality Evaluation of Production Instruments
- Criticality Evaluation of HVAC System Device
🧭 Criticality Evaluation of Instruments in Pharma
✅ What is Criticality Evaluation?
Criticality evaluation is the process of assessing instruments to determine their impact on product quality, patient safety, and regulatory compliance.
This helps you:
- Classify instruments as critical, major, or non-critical.
- Define qualification, calibration, and maintenance requirements.
- Allocate risk-based controls and priorities.
🎯 Why is it Important?
Regulatory guidelines (EU GMP, FDA, WHO) expect manufacturers to:
- Identify equipment that can directly or indirectly affect product quality.
- Apply appropriate control measures.
- Ensure data integrity and traceability of critical measurements.
🛠️ How is Criticality Determined?
You typically evaluate based on:
| Factor | Question |
|---|---|
| Direct Product Impact? | Does the instrument measure or control parameters that directly affect product quality? |
| Decision Impact? | Does it provide data used for batch release or acceptance/rejection? |
| Regulatory Relevance? | Is it required by GMP guidelines or pharmacopeia standards? |
| Process Control Role? | Is it part of a critical process control system (e.g., sterilization, blending)? |
| Data Integrity Impact? | Does it generate GxP records requiring traceability and security? |
✅ Example Instrument Criticality Classification Table:
| Instrument | Use | Criticality |
|---|---|---|
| Autoclave Temperature Sensor | Controls sterilization cycle | Critical |
| Balance (API Weighing) | Determines batch potency | Critical |
| pH Meter (Cleaning Validation) | Confirms cleaning effectiveness | Critical |
| Tablet Hardness Tester | Routine in-process monitoring | Major |
| Warehouse Temperature Logger | Storage condition monitoring (controlled ambient) | Major |
| Utility Pressure Gauge | Non-GMP compressed air monitoring | Non-Critical |
🧪 Typical Classification Categories
- Critical Instruments
- Directly impact product quality or regulatory compliance.
- Require full qualification, periodic calibration, and strict controls.
- Major Instruments
- Indirectly affect product quality.
- Require qualification and routine checks.
- Non-Critical Instruments
- No significant impact on quality.
- Basic verification or calibration only.
📘 Reference Guidelines
- EU GMP Annex 15 – Qualification and Validation
- WHO TRS 1019 Annex 3 – Equipment Qualification
- ISPE GAMP 5 – Risk-Based Approach
- FDA Guidance for Industry – Process Validation