Procedure for Conducting Equipment Validation
| Department | Quality Assurance (QA)/Engineering/Production |
|---|---|
| SOP No. | SOP/Ointment/117 |
| 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 systematic approach for conducting equipment validation in ointment manufacturing. Equipment validation ensures that all machinery and systems used in production meet predetermined specifications and regulatory compliance requirements.
2. Scope
This SOP applies to all personnel in the Quality Assurance (QA), Engineering, and Production departments responsible for equipment qualification, performance verification, and validation activities.
3. Responsibilities
- Engineering Team: Performs installation and ensures equipment readiness.
- QA Officer: Monitors validation activities and ensures compliance with GMP.
- Validation Team: Executes validation protocols and documents findings.
- Production Supervisor: Ensures adherence to validated operational parameters.
- QA Manager: Approves validation protocols and final validation reports.
4. Accountability
The QA and Engineering Managers are accountable for ensuring that equipment validation is conducted as per GMP, FDA, ICH, and WHO guidelines.
5. Procedure
5.1 Equipment Validation Phases
- Equipment validation is conducted in three main phases:
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Each phase must be documented, reviewed, and approved before progressing to the next stage.
5.2 Installation Qualification (IQ)
- Verify the correct installation of equipment as per manufacturer specifications.
- Ensure that utilities (electrical, air, water)
are properly connected and functional.
Confirm that all required components, instruments, and safety features are installed.
Document serial numbers, equipment specifications, and installation checks.
QA must approve the IQ report before proceeding to the OQ phase.
5.3 Operational Qualification (OQ)
- Assess equipment functionality under normal operating conditions.
- Conduct test runs to verify operational parameters (temperature, pressure, speed, etc.).
- Ensure safety features and interlocks function correctly.
- Record data and compare results with predefined acceptance criteria.
- Investigate and resolve any deviations before proceeding to PQ.
5.4 Performance Qualification (PQ)
- Validate equipment performance under actual production conditions.
- Use at least three consecutive production runs to confirm repeatability.
- Collect and analyze quality control data (assay, viscosity, homogeneity, etc.).
- Verify that the equipment consistently produces batches meeting product specifications.
- Document and approve PQ results before commercial production.
5.5 Requalification and Periodic Validation
- Conduct periodic requalification of equipment as per predefined schedules.
- Validate equipment after major maintenance, modifications, or relocation.
- Maintain a validation status log for all critical equipment.
5.6 Validation Report and Approval
- Compile all validation data into an Equipment Validation Report.
- QA and Engineering must jointly review and approve the final report.
- Maintain all validation records for regulatory audits.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- OQ – Operational Qualification
- IQ – Installation Qualification
- PQ – Performance Qualification
7. Documents
- Equipment Qualification Protocol (Annexure-1)
- Equipment Validation Report (Annexure-2)
8. References
- ICH Q9 – Quality Risk Management
- WHO GMP Guidelines for Equipment Qualification
- US FDA Guidance on 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: Equipment Qualification Protocol
| Validation Parameter | Specification | Acceptance Criteria |
|---|---|---|
| Temperature Control | ±2°C | Within Limits |
| Mixing Speed | 500-1500 rpm | Compliant |
| Sealing Integrity | No leakage | 100% Compliance |
Annexure-2: Equipment Validation Report
| Equipment ID | Test Parameter | Result | Final Approval |
|---|---|---|---|
| MIX-2001 | Temperature Stability | Compliant | QA Manager |
| FILL-3002 | Sealing Integrity | 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 |