Standard Operating Procedure for Use of Water for Injection (WFI) in Elixir Production
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/058/2025 |
| Supersedes | SOP/ELX/058/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To establish a standard procedure for the use, handling, and quality control of Water for Injection (WFI) in the manufacturing of elixir formulations to ensure compliance with GMP requirements.
2. Scope
This SOP applies to all activities involving the collection, transfer, usage, and documentation of WFI in elixir manufacturing in the Elixir Department.
3. Responsibilities
- Production Operator:
- Collect and use WFI in accordance with batch requirements and specifications.
- Ensure proper line flushing and container sanitization before collection.
- Production Supervisor:
- Verify WFI collection process and temperature.
- Monitor that WFI is used within the hold time limit.
- QA Officer:
- Perform sampling and release of WFI prior to use.
- Ensure all WFI usage is traceable in documentation.
4. Accountability
The Production Head is accountable for ensuring that WFI is used as per specifications and no microbial or endotoxin risk is introduced into the batch.
5. Procedure
5.1 WFI Collection
- Ensure the WFI loop is in validated state and operating above 80°C in circulation mode.
- Flush the sampling point or user valve for at least 2 minutes before collection.
- Sanitize the outer nozzle of the user point with 70% IPA.
- Collect WFI in pre-cleaned, stainless steel or HDPE containers labeled with:
- “WFI – For Manufacturing Use Only”
- Date and Time of Collection
- Collected By
5.2 Quality Control of WFI
- Send samples to QC for analysis of the following:
- Conductivity
- Total Organic Carbon (TOC)
- Microbial Load
- Endotoxin Level (if applicable)
- WFI shall be used only after release by QA based on results.
5.3 Usage Guidelines
- Use WFI only within 4 hours of collection if stored below 25°C, or within 8 hours if maintained at ≥70°C.
- Do not reuse WFI from previous batches.
- Document the WFI quantity used, batch number, and time in the BMR and WFI Usage Log (Annexure-1).
5.4 Cleaning After Use
- Clean and dry all WFI collection containers after use.
- Label containers as “Cleaned” with date and signature.
6. Abbreviations
- WFI: Water for Injection
- TOC: Total Organic Carbon
- QA: Quality Assurance
- SOP: Standard Operating Procedure
- BMR: Batch Manufacturing Record
7. Documents
- WFI Usage Log (Annexure-1)
- WFI Sampling and Test Report (Annexure-2)
- WFI Container Cleaning Log (Annexure-3)
8. References
- USP Monograph on Water for Injection
- WHO TRS 970 – Annex 2: Pharmaceutical Water Systems
- 21 CFR Part 211.110 – Sampling and Testing
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: WFI Usage Log
| Date | Batch No. | WFI Qty (L) | Time Collected | Used By | Verified By |
|---|---|---|---|---|---|
| 11/04/2025 | ELX-1004 | 100 | 09:00 AM | Rajesh Kumar | Sunita Reddy |
Annexure-2: WFI Sampling and Test Report
| Parameter | Limit | Result | Status |
|---|---|---|---|
| Conductivity | < 1.3 µS/cm | 0.9 µS/cm | Pass |
| TOC | < 500 ppb | 320 ppb | Pass |
| Microbial Load | < 10 CFU/100 mL | 2 CFU | Pass |
Annexure-3: WFI Container Cleaning Log
| Date | Container ID | Cleaned By | Verified By | Status |
|---|---|---|---|---|
| 11/04/2025 | WFI-C-01 | Ajay Desai | Manju Sharma | Cleaned |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Issue | New SOP | QA Head |
| 11/04/2025 | 2.0 | Added TOC Testing and Hold Time Limits | Regulatory Compliance | QA Head |