Procedure for Validation of Automated Equipment
| Department | Quality Assurance (QA)/Validation/Engineering/Production |
|---|---|
| SOP No. | SOP/Ointment/138 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the process for validating automated equipment used in ointment manufacturing. This ensures that automated systems perform as intended and meet regulatory compliance requirements.
2. Scope
This SOP applies to all personnel in the Quality Assurance (QA), Validation, Engineering, and Production departments responsible for the validation of automated equipment such as automated mixing systems, filling lines, and control systems.
3. Responsibilities
- QA Officer: Ensures compliance with validation protocols.
- Validation Team: Develops validation protocols and executes testing.
- Engineering Team: Supports software and hardware verification.
- Production Supervisor: Ensures adherence to validation testing procedures.
- QA Manager: Approves validation reports and maintains documentation.
4. Accountability
The QA and Validation Managers are accountable for ensuring that automated equipment validation is conducted as per GMP, FDA, ICH, and WHO guidelines.
5. Procedure
5.1 Phases of Automated Equipment Validation
- Validation consists of the following phases:
- Design Qualification (DQ): Ensures equipment design meets process requirements.
- Installation Qualification (IQ): Confirms proper installation of hardware and software.
- Operational Qualification (OQ): Verifies system functionality and automation processes.
- Performance Qualification (PQ): Ensures automated equipment performs reliably under real
production conditions.
5.2 Design Qualification (DQ)
- Verify that automated equipment design meets operational requirements.
- Review system specifications, control logic, and fail-safes.
- Document compliance with regulatory standards.
5.3 Installation Qualification (IQ)
- Ensure proper installation of hardware, software, and control panels.
- Confirm power supply, network connections, and integration with other systems.
- Verify firmware/software versions and document security settings.
5.4 Operational Qualification (OQ)
- Test automated system responses to predefined commands.
- Ensure control mechanisms, safety interlocks, and alarms function correctly.
- Validate process parameters such as:
- Mixing speed automation
- Temperature regulation
- Automated fill volume adjustment
- Record test results and document any deviations.
5.5 Performance Qualification (PQ)
- Run test batches to assess repeatability and reliability of automation.
- Ensure consistency in:
- Product weight and fill volume
- Mixing efficiency
- Sealing and labeling accuracy
- Document performance data and approve final validation.
5.6 Handling Deviations
- If automated equipment fails validation criteria:
- Investigate root cause of failure.
- Implement corrective and preventive actions (CAPA).
- Retest system after corrective measures.
- All deviations must be recorded and reviewed by QA.
5.7 Documentation and Review
- Maintain all validation records in the Automated Equipment Validation Log.
- QA must review and approve all validation reports.
- Ensure validation data is available for regulatory audits.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- IQ – Installation Qualification
- OQ – Operational Qualification
- PQ – Performance Qualification
- DQ – Design Qualification
- CAPA – Corrective and Preventive Actions
7. Documents
- Automated Equipment Validation Protocol (Annexure-1)
- Automated Equipment Validation Log (Annexure-2)
8. References
- ICH Q7 – Good Manufacturing Practice Guide
- WHO Guidelines for Equipment Validation
- US FDA Guidance on Automated Equipment Validation
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Automated Equipment Validation Protocol
| Equipment Type | Validation Phase | Test Parameter | Acceptance Criteria |
|---|---|---|---|
| Filling Machine | OQ | Fill Volume Accuracy | ± 1% of set volume |
| Mixing System | PQ | Agitation Speed | ± 5% of set value |
Annexure-2: Automated Equipment Validation Log
| Date | Equipment ID | Validation Phase | Test Performed | Result | Reviewed By |
|---|---|---|---|---|---|
| 01/02/2025 | FILL-1001 | OQ | Fill Volume Test | Pass | QA Manager |
| 02/02/2025 | MIX-2002 | PQ | Mixing Speed Test | Pass | QA Manager |
12. Revision History:
| Revision Date | Revision No. | Details of Revision | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head |