Standard Operating Procedure for Use of Mobile IPC Labs in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/208/2025 |
| Supersedes | SOP/ELX/208/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To define the procedure for operation, maintenance, and utilization of Mobile In-Process Control (IPC) Laboratories during elixir manufacturing to enable real-time testing, faster decision-making, and regulatory compliance.
2. Scope
This SOP applies to the use of mobile IPC labs for conducting physical and chemical tests such as pH, weight per mL, clarity, and assay within the manufacturing area of the Elixir Department. It includes equipment handling, sample testing, documentation, and data transmission.
3. Responsibilities
- QC Analyst:
- Operate mobile lab equipment, perform testing, and document results.
- Production Operator:
- Coordinate sample provision and ensure space for mobile lab access.
- QA Officer:
- Verify test records and approve the use of results for batch decision-making.
4. Accountability
The QC Head is accountable for the operation and calibration of mobile IPC labs. QA ensures documentation, audit readiness, and compliance.
5.
Procedure
5.1 Setup of Mobile IPC Lab
- Verify that the mobile IPC trolley contains:
- Portable pH meter
- Analytical balance (portable)
- Conductivity meter (if required)
- Glassware, reagents, calibrated pipettes
- Power supply and battery backup
- Ensure all instruments are calibrated and within validity period.
- Position mobile IPC lab near the manufacturing tank or designated IPC station.
5.2 Performing Tests
- Collect samples in pre-labeled containers as per the sampling plan.
- Perform the required tests (e.g., pH, weight per mL, clarity) within 15 minutes of sampling.
- Record the results directly into the IPC mobile lab logbook and/or electronic tablet (if used).
- Ensure test results are reviewed by QA before batch continuation.
5.3 Cleaning and Maintenance
- Clean all glassware and wipe down instruments with lint-free cloth post-usage.
- Disinfect surfaces using 70% IPA before moving between production areas.
- Check and charge backup batteries at the end of the shift.
5.4 Data Handling
- All data should be captured:
- Manually in the Mobile IPC Logbook (Annexure-1)
- Digitally using validated electronic systems (if available)
- Results must be transcribed into the BMR and signed by the analyst and QA.
5.5 Movement Protocol
- Before relocating the mobile IPC lab to a new batch or room:
- Wipe all surfaces
- Cover sensitive instruments
- Secure mobile unit with brakes and stability locks during transport
6. Abbreviations
- IPC: In-Process Control
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- QC: Quality Control
- BMR: Batch Manufacturing Record
- IPA: Isopropyl Alcohol
7. Documents
- Mobile IPC Lab Logbook (Annexure-1)
- Equipment Calibration Log
- Batch Manufacturing Record (BMR)
8. References
- 21 CFR Part 211.110 – Sampling and Testing of In-Process Materials
- ICH Q10 – Pharmaceutical Quality System
- WHO TRS 986 – GMP Guidelines
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Mobile IPC Lab Logbook
| Date | Batch No. | Parameter | Result | Specification | Tested By | QA Review |
|---|---|---|---|---|---|---|
| 11/04/2025 | ELX-0425-026 | pH | 6.9 | 6.5 – 7.5 | Rajesh Kumar | Sunita Reddy |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Release | New SOP | QA Head |
| 11/04/2025 | 2.0 | Inclusion of mobility and electronic data capture | Process Optimization | QA Head |