Procedure for Validation of HVAC Systems
| Department | Quality Assurance (QA)/Validation/Engineering/Production |
|---|---|
| SOP No. | SOP/Ointment/141 |
| 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 establish a systematic approach for the validation of HVAC (Heating, Ventilation, and Air Conditioning) systems in ointment manufacturing. This ensures that HVAC systems maintain controlled environmental conditions necessary for compliance with regulatory standards.
2. Scope
This SOP applies to all personnel in the Quality Assurance (QA), Validation, Engineering, and Production departments responsible for HVAC system qualification, validation, and routine monitoring.
3. Responsibilities
- QA Officer: Ensures compliance with HVAC validation protocols.
- Validation Team: Develops and executes HVAC validation protocols.
- Engineering Team: Maintains HVAC equipment and ensures calibration of monitoring devices.
- Production Supervisor: Ensures that validated HVAC conditions are maintained in manufacturing areas.
- QA Manager: Reviews and approves HVAC validation reports.
4. Accountability
The QA and Engineering Managers are accountable for ensuring that HVAC validation is conducted as per GMP, FDA, ICH, and WHO guidelines.
5. Procedure
5.1 Phases of HVAC System Validation
HVAC system validation follows three key phases:
- Installation Qualification (IQ): Verifies that HVAC equipment is installed according to specifications.
- Operational Qualification (OQ): Ensures that the HVAC system operates as designed under set parameters.
- Performance
Qualification (PQ): Validates HVAC system performance under actual production conditions.
5.2 Installation Qualification (IQ)
- Verify HVAC system installation against design specifications.
- Check system components, including:
- Air Handling Units (AHUs)
- Filters (HEPA, pre-filters)
- Ductwork and ventilation
- Temperature and humidity control units
- Ensure proper calibration of sensors and monitors.
- Document installation records and approve IQ reports.
5.3 Operational Qualification (OQ)
- Test the HVAC system to verify operational effectiveness.
- Evaluate system performance under different conditions:
- Temperature uniformity
- Humidity control
- Air pressure differentials
- Airflow velocity and direction
- Check the effectiveness of alarms and control mechanisms.
- Record OQ data and approve reports before proceeding to PQ.
5.4 Performance Qualification (PQ)
- Assess HVAC system stability under actual production conditions.
- Monitor environmental parameters over multiple production cycles.
- Conduct air quality testing, including:
- Particulate matter count
- Microbial load testing
- Filter efficiency tests
- Ensure that HVAC conditions meet GMP requirements.
- Document and approve PQ results before final validation approval.
5.5 Routine Monitoring and Revalidation
- Schedule routine HVAC performance monitoring.
- Conduct periodic revalidation after major maintenance or modifications.
- Ensure continuous logging of temperature, humidity, and pressure differentials.
5.6 Handling Deviations
- If HVAC system fails validation criteria:
- Identify root cause and document findings.
- Implement corrective and preventive actions (CAPA).
- Requalify HVAC system after adjustments.
- Maintain all deviation records for regulatory audits.
5.7 Documentation and Review
- Maintain all validation records in the HVAC Validation Log.
- QA must review and approve all validation reports.
- Ensure records are available for regulatory inspections.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- IQ – Installation Qualification
- OQ – Operational Qualification
- PQ – Performance Qualification
- CAPA – Corrective and Preventive Actions
- HEPA – High-Efficiency Particulate Air
- AHU – Air Handling Unit
7. Documents
- HVAC Validation Protocol (Annexure-1)
- HVAC Validation Log (Annexure-2)
8. References
- ICH Q7 – Good Manufacturing Practice Guide
- WHO Guidelines for HVAC Validation
- US FDA Guidance on HVAC Systems in Pharmaceutical Facilities
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: HVAC Validation Protocol
| HVAC Component | Validation Phase | Test Parameter | Acceptance Criteria |
|---|---|---|---|
| HEPA Filters | PQ | Filtration Efficiency | ≥99.97% for 0.3 µm particles |
| Air Handling Unit | OQ | Temperature Uniformity | ± 2°C of setpoint |
Annexure-2: HVAC Validation Log
| Date | HVAC ID | Validation Phase | Test Performed | Result | Reviewed By |
|---|---|---|---|---|---|
| 01/02/2025 | AHU-1001 | IQ | Installation Verification | Pass | QA Manager |
| 02/02/2025 | FILTER-2002 | PQ | HEPA Efficiency 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 |