Design Qualification of Balance done after the User requirement specification. URS followed by design review followed by Factory acceptance criteria and Site acceptance criteria and then Design Qualification followed by Installation, Operation and then Performance qualification.
Objective of Design Qualification of Balance
To document and verify that the selected weighing balance is suitably designed and specified to meet the intended use, process requirements, regulatory requirements, data integrity requirements, and Good Manufacturing Practice (GMP) requirements before procurement, installation, and operation.
Scope
This Design Qualification protocol applies to the weighing balance intended for use in pharmaceutical manufacturing, dispensing, sampling, laboratory testing, or quality control activities.
The qualification includes:
- User Requirement Specification (URS) verification
- Equipment design review
- Regulatory compliance review
- Supplier assessment
- Calibration requirements
- Data integrity requirements
- Environmental suitability assessment
- Safety assessment
References
- EU GMP Annex 15 – Qualification and Validation
- WHO GMP Guidelines
- PIC/S GMP Guide
- 21 CFR Part 211
- User Requirement Specification (URS)
Responsibilities
| Department | Responsibility |
| User Department | Define requirements and intended use |
| Engineering | Technical review and installation requirements |
| Quality Assurance | Review and approval of DQ |
| Validation | Execution and documentation of DQ |
| Supplier/Vendor | Provision of technical documents |
Equipment Description related to Design Qualification of Balance
The weighing balance is intended for accurate weighing of raw materials, intermediates, standards, samples, and finished products.
Equipment Details
| Parameter | Description |
| Equipment Name | Weighing Balance |
| Manufacturer | _________ |
| Model | _________ |
| Capacity | _________ |
| Readability | _________ |
| Accuracy Class | _________ |
| Power Supply | _________ |
| Display Type | _________ |
| Calibration Type | Internal / External |
| Communication Ports | USB / RS232 / Ethernet |
| Software Version | _________ |
Intended Use
The weighing balance shall be used for:
- Raw material dispensing
- Sample preparation
- Analytical testing
- Standard preparation
- In-process checks
The balance shall provide accurate and reproducible measurements within defined tolerances.
User Requirement Specification Verification
URS Compliance Matrix
| URS Requirement | Acceptance Criteria | Compliance (Y/N) | Remarks |
| Required weighing range available | Meets process requirement | ||
| Readability suitable | As per URS | ||
| Accuracy acceptable | Manufacturer specification meets URS | ||
| Internal calibration available | Yes/No per URS | ||
| External calibration possible | Yes | ||
| GLP/GMP print capability | Available | ||
| Password protection | Available | ||
| Audit trail capability (if applicable) | Available | ||
| Data export facility | Available | ||
| Environmental suitability | Suitable for installation area | ||
| Compliance certificates available | Available |
Design Review
Mechanical Design Assessment
| Requirement | Acceptance Criteria | Status |
| Robust construction | Suitable for pharmaceutical environment | |
| Corrosion-resistant material | Stainless steel or equivalent | |
| Easy cleaning design | No inaccessible surfaces | |
| Stable weighing platform | No excessive vibration | |
| Leveling arrangement | Provided |
Calibration Assessment
| Requirement | Acceptance Criteria | Status |
| Calibration possible using certified weights | Yes | |
| Traceability to national standards | Available | |
| Calibration SOP available | Yes | |
| Calibration frequency defined | Yes |
Safety Assessment
| Requirement | Acceptance Criteria | Status |
| Electrical safety certification | Available | |
| Operator safety risk acceptable | Yes | |
| Sharp edges absent | Yes | |
| Emergency instructions available | Yes |
Documentation Review details for Design Qualification of Balance
The following documents shall be available:
| Document | Available (Y/N) |
| User Manual | |
| Technical Specification | |
| Calibration Certificate | |
| Warranty Certificate | |
| Material Certificates | |
| Software Documentation | |
| IQ/OQ Recommendations | |
| Service Manual |
Risk Assessment Summary
| Risk | Impact | Mitigation | Residual Risk |
| Incorrect weighing | Product quality | Calibration program | Low |
| Environmental interference | Measurement error | Controlled environment | Low |
| Software failure | Data integrity issue | Backup and audit trail | Low |
| Power interruption | Data loss | UPS/backup | Low |
Design Qualification Acceptance Criteria
The weighing balance shall be considered design qualified if:
- All URS requirements are met.
- Design is suitable for intended use.
- GMP requirements are satisfied.
- Calibration requirements are defined.
- Environmental requirements are acceptable.
- Data integrity requirements are addressed.
- Required documentation is available.
- No critical deviations remain open.
Deviations
| Deviation No. | Description | Impact Assessment | Resolution |
Conclusion for Design Qualification of Balance
Based on the review of design specifications, technical documentation, URS compliance, risk assessment, and GMP requirements, the weighing balance:
Meets all design requirements and is approved for procurement and qualification.
Does not meet all design requirements and requires corrective action before approval.