Procedure for Maintaining Records of Utility Validation
| Department | Quality Assurance (QA)/Validation/Engineering |
|---|---|
| SOP No. | SOP/Ointment/148 |
| 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 a structured process for maintaining records related to utility validation. Proper documentation ensures compliance with regulatory standards, facilitates audits, and allows continuous monitoring of utilities such as HVAC, water systems, compressed air, and electrical supply.
2. Scope
This SOP applies to all personnel in the Quality Assurance (QA), Validation, and Engineering departments responsible for maintaining and managing records of utility validation.
3. Responsibilities
- QA Officer: Ensures compliance with documentation protocols.
- Validation Team: Collects and archives validation records.
- Engineering Team: Ensures accurate logging of utility performance data.
- QA Manager: Reviews and approves validation records.
4. Accountability
The QA and Engineering Managers are accountable for ensuring that all records related to utility validation are maintained as per GMP, FDA, ICH, and WHO guidelines.
5. Procedure
5.1 Types of Records to be Maintained
The following records must be maintained for utility validation:
- Validation Protocols: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Utility Performance Logs: Daily, weekly, and monthly performance records of utilities.
- Trend Analysis Reports: Periodic assessments of utility performance over
time.
Deviation and CAPA Reports: Documentation of any deviations and associated corrective actions.
Calibration Records: Logs of calibration and maintenance of monitoring instruments.
5.2 Documentation Format and Storage
- All records should be maintained in both physical and digital formats.
- Each document must have:
- Title and document number
- Issue and revision date
- Authorized signatures
- Storage locations must be secure and accessible to authorized personnel only.
5.3 Data Entry and Record Keeping
- Data must be recorded in real-time.
- Entries must be legible, signed, and dated.
- Corrections should follow ALCOA+ principles:
- Attributable
- Legible
- Contemporaneous
- Original
- Accurate
5.4 Retention and Archival of Records
- Utility validation records should be retained for a minimum of five years or as per regulatory requirements.
- Archived records should be:
- Indexed properly for easy retrieval.
- Protected from environmental damage (e.g., moisture, heat).
- Digital records should have backup copies stored in secure locations.
5.5 Review and Approval Process
- All records should be reviewed by the QA Manager.
- Deviations and corrective actions should be assessed and approved before final documentation.
- Periodic audits should be conducted to verify record integrity.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- HVAC – Heating, Ventilation, and Air Conditioning
- CAPA – Corrective and Preventive Actions
- OOS – Out of Specification
7. Documents
- Utility Validation Log (Annexure-1)
- Document Control Register (Annexure-2)
8. References
- ICH Q7 – Good Manufacturing Practice Guide
- WHO Guidelines for Utility Validation
- US FDA Guidance on Documentation Practices
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Utility Validation Log
| Date | Utility Type | Parameter Monitored | Recorded Value | Acceptance Criteria | Reviewed By |
|---|---|---|---|---|---|
| 01/02/2025 | HVAC | Room Temperature | 22°C | 20-24°C | QA Manager |
| 02/02/2025 | Water System | Conductivity | 1.2 µS/cm | ≤ 1.3 µS/cm | QA Manager |
Annexure-2: Document Control Register
| Document ID | Document Name | Version | Issue Date | Retention Period | Reviewed By |
|---|---|---|---|---|---|
| UV-001 | HVAC Validation Report | 2.0 | 01/01/2025 | 5 Years | QA Manager |
| UV-002 | Compressed Air Validation Log | 2.0 | 02/01/2025 | 5 Years | QA Manager |