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Qualification: Qualification is objective evidence that equipment or system and its ancillary systems are correctly installed, work as expected, and fit for the intended use. -Crux of all definitions
Validation: Validation is the collection and assessment of data from process design to commercial phase, which establishes objective evidence that a process can consistently deliver a quality product. Crux of all definitions
Besides this, utilities, sometimes, also require validation based on risk assessment during the process development phase.
Critical utilities may include the electrical accessories, HVAC, Vacuum, WFI, Pure Steam, Purified Water, etc.
For utilities with controllable input-output, qualification may be sufficient and may not require validation.
Sometimes, equipment may require process validation instead of qualification if used for critical manufacturing steps. This makes sense as we challenge the equipment to show reproducible results for the critical operations.
Interpretation of these two terms slightly varies for medical devices compared to pharmaceuticals; however, the intent remains the same.
Medical devices follow ISO-13485 and 21 CFR Part 820 guidelines for these two approaches.
Here are the key differences between them.
| Qualification | Validation |
|---|---|
| Is mainly for equipment and instruments. | Is mainly for: – Manufacturing process – Cleaning – Computer System – Software – Test Methods and sometimes for equipment used for critical process operations. |
| Used to challenge the performance of equipment. | Used to challenge the performance of processes. |
| Requirements include: URS, FDS, DQ, IQ, OQ, PQ, Calibration, Maintenance, etc. |
Requirements include: 1. Process Design 2. Process Verification 3. Process Confirmation 4. Process Qualification Different types of Validation are: |
| Does not demand a reproducible outcome. Only concerned about the proper functioning of the system and sub-systems. | Specifically intended to challenge reproducible outcomes. |
| Ensures the equipment or system and its sub-systems are installed correctly, operate as required, and perform as intended. | Ensures the process is capable of producing consistent results within the approved specifications. |
| Qualification is a part of Validation. | Validation is big umbrella under which Qualification is one vertical. |
| To qualify the system, required documents are: URS, FDS, DQ, IQ, OQ, PQ, Calibration, Maintenance, etc. |
For validation, required documents are: – SOPs – Qualification Status Report – Validation Master Plan – Validation Strategy – Validation Protocol – Validation Final Report |
| Mostly, qualification of various equipment can be performed simultaneously.
So, this can go in parallel. |
Within validation, supporting processes require validation prior to validating the key process.
And this goes in series. |
| Re-qualification is needed for: 1. Significant modifications critical to the outcome 2. Post relocation 3. Software and control modifications 4. Periodic Schedule |
Re-validation is needed for any changes in: 1. Process or its environment 2. Starting material 3. Packing material 4. Steps or Procedure 5. Equipment 6. Periodic Schedule |
