Standard Operating Procedure for Verification of IPC Equipment Status in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/113/2025 |
| Supersedes | SOP/API/113/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To establish a systematic procedure for verifying the operational status, calibration, and cleanliness of IPC (In-Process Control) equipment used during API manufacturing, ensuring consistent and reliable results in compliance with cGMP guidelines.
2. Scope
This SOP applies to all IPC equipment such as pH meters, conductivity meters, thermometers, LOD balances, and TLC kits used within production areas for routine in-process
checks of API batches.
3. Responsibilities
- Production Chemist: Check and record the equipment status before each use, escalate abnormalities to QA.
- QA Officer: Verify log entries, conduct random checks, and ensure compliance with calibration schedules.
- Engineering/Maintenance: Perform preventive maintenance and address reported malfunctions.
4. Accountability
The Production Head is accountable for ensuring that IPC equipment is verified before use. The QA Head is responsible for ensuring compliance and documentation as per SOP.
5. Procedure
5.1 List of IPC Equipment Requiring Verification
- Digital/Handheld pH Meters
- Conductivity Meters
- Thermometers/Temperature Indicators
- LOD Balances
- Refractometers
- TLC Kits/Plates and Visualization Lamps
5.2 Pre-Use Verification Steps
- Check for Calibration Status:
- Verify last calibration date and due date on equipment label.
- Do not use equipment if calibration is overdue—report immediately to QA.
- Check for Cleanliness and Physical Condition:
- Inspect equipment for visible residues, dust, cracks, or damages.
- Clean surfaces with lint-free cloth or as per equipment-specific SOPs.
- Check for Functionality:
- Power on the device and perform a self-check (if applicable).
- Measure a standard solution (e.g., pH 7 buffer or 1413 µS/cm conductivity standard) to verify performance.
- Record status in the IPC Equipment Verification Logbook (Annexure-1) before use.
5.3 During-Use Monitoring
- Observe equipment response and performance during measurement.
- Any drift, error message, or erratic readings must be reported and equipment taken out of service.
- Replace or troubleshoot the unit as per maintenance SOPs before reuse.
5.4 Post-Use Practices
- Switch off and clean the equipment immediately after use.
- Place it back in the designated storage cabinet or dry area with proper labeling.
5.5 Deviation Handling
- In case of:
- Uncalibrated equipment use
- Malfunctioning equipment
- Unrecorded verification
raise a deviation report and assess impact on process data with QA.
6. Abbreviations
- SOP: Standard Operating Procedure
- IPC: In-Process Control
- QA: Quality Assurance
- LOD: Loss on Drying
- cGMP: Current Good Manufacturing Practices
7. Documents
- IPC Equipment Verification Logbook (Annexure-1)
- Deviation Form (if applicable)
- Calibration Certificate
8. References
- ICH Q7 – GMP Guidelines for API
- 21 CFR Part 211 – US FDA cGMP
- WHO TRS 986 – Annex 2
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: IPC Equipment Verification Logbook
| Date | Equipment | Equipment ID | Calibration Due | Status | Checked By | Remarks |
|---|---|---|---|---|---|---|
| 13/04/2025 | pH Meter | PHM-102 | 30/06/2025 | OK | Ravi Kumar | Clean and Calibrated |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial Issue | New SOP | QA Head |
| 13/04/2025 | 2.0 | Incorporated additional verification points and deviation clause | Audit Finding | QA Head |