Standard Operating Procedure for Recording Utility Validation Data in Gel Manufacturing
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/150/2025 |
| Supersedes | SOP/GM/150/2022 |
| Page No. | Page 1 of 12 |
| Issue Date | 09/06/2025 |
| Effective Date | 11/06/2025 |
| Review Date | 09/06/2027 |
1. Purpose
To establish a standardized procedure for documenting utility validation data, including purified water, compressed air, nitrogen, HVAC, and clean steam systems used in gel manufacturing operations.
2. Scope
This procedure applies to all utilities that support the manufacturing, cleaning, or environmental control of gel products in the facility.
3. Responsibilities
- Validation Engineer: Collects utility data and completes validation data sheets.
- QA Executive: Verifies and reviews data for compliance and completeness.
- Engineering Department: Supports measurement and calibration of utility instrumentation.
4. Accountability
The Head – Manufacturing shall ensure that all utility validation data is
accurately recorded, reviewed, and retained for regulatory and internal audits.
5. Procedure
5.1 Preparation of Utility Validation Template
- Prepare or download standardized utility validation templates for each utility system.
- Include fields for system description, sampling locations, acceptance criteria, and results.
5.2 Data Collection
- Conduct sampling as per approved validation protocol for each utility.
- Ensure calibration of all monitoring instruments before use.
- Record readings for parameters like microbial load, TOC, conductivity, differential pressure, temperature, and particle counts.
5.3 Data Entry and Verification
- Enter results immediately into the respective data sheet using black permanent ink.
- Any corrections must be countersigned with date and reason.
- QA shall cross-verify the data against raw outputs and instrument logs.
5.4 Data Review and Approval
- Each completed data sheet must be reviewed and signed by QA.
- Attach any supporting printouts or graphs (e.g., TOC analyzer output, particle counter reports).
- Final utility qualification report shall include compiled and approved data sheets.
5.5 Data Storage and Retention
- Store all validated data in a secure central archive room under QA custody.
- Soft copies to be maintained in the Document Management System (DMS).
- Retention period shall be a minimum of 5 years or as per regulatory requirement.
6. Abbreviations
- TOC: Total Organic Carbon
- DMS: Document Management System
- QA: Quality Assurance
- CFU: Colony Forming Unit
- HVAC: Heating, Ventilation, and Air Conditioning
7. Documents
- Utility Validation Protocol
- Utility Validation Data Sheet – Annexure-1
- Utility System Qualification Report – Annexure-2
- Calibration Records – Annexure-3
8. References
- WHO TRS 1010 Annex 4: GMP for HVAC Systems
- ISPE Baseline Guide – Volume 4: Water and Steam Systems
- USP <1231>: Water for Pharmaceutical Purposes
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Jr. Production Chemist | QA Executive | Head – Manufacturing |
| Department | Gel Manufacturing | Quality Assurance | Manufacturing |
11. Annexures
Annexure-1: Utility Validation Data Sheet
| Utility | |
|---|---|
| Sampling Location | |
| Parameter Tested | |
| Observed Value | |
| Acceptance Criteria | |
| Pass/Fail | |
| Tested By | |
| Date |
Annexure-2: Utility System Qualification Report
(Attach signed summary report with data tables, graphs, and conclusion)
Annexure-3: Calibration Records
| Instrument | Calibration Date | Due Date | Calibrated By | Status |
|---|---|---|---|---|
Revision History
| Revision Date | Revision No. | Change Description | Reason | Approved By |
|---|---|---|---|---|
| 22/03/2022 | 1.0 | Initial SOP for utility data | New equipment installed | QA Head |
| 09/06/2025 | 2.0 | Incorporated Annexures and structured DMS archival | Annual Review | QA Head |