involved in the gel manufacturing process where IPC tests such as pH, viscosity, appearance, weight variation, and temperature are conducted and documented.

3. Responsibilities

• Operators: Perform IPC checks as per instructions and fill data in real-time.
• Production Chemist: Review IPC data and ensure it is within specifications.
• QA Personnel: Verify completeness, accuracy, and regulatory compliance of IPC records.

4. Accountability

Head – Manufacturing is accountable for ensuring proper documentation and timely reporting of IPC data for all gel batches.

5. Procedure

5.1 In-Process Testing Stages

1. At various critical stages of gel production (e.g., post-mixing, post-homogenization, during filling), designated IPC parameters must be tested and recorded.
2. Typical IPC parameters for gels include:
   • pH
   • Viscosity
   • Appearance
   • Temperature
   • Weight variation of filled tubes
   • Homogeneity

5.2 Recording IPC Data

1. Use the approved “In-Process Control Record” format (Annexure-1).
2. Enter results immediately after test completion to ensure real-time traceability.
3. Include tester’s name, date, time, equipment ID, and any deviation observed.
4. All entries must be legible, in indelible ink, and without overwriting. Corrections should be countersigned with justification.

5.3 Review and Verification

1. Production Chemist shall review all IPC entries within the same shift for completeness and compliance.
2. QA shall verify critical parameters before approving batch continuation or release to the next stage.
3. IPC results outside specifications must be escalated immediately and managed per deviation handling SOP.

5.4 Data Reporting and Archiving

1. Summarize IPC data in the Batch Manufacturing Record (BMR).
2. Submit completed IPC records to QA within 24 hours of batch completion.
3. QA shall retain IPC records as part of batch documentation for a minimum of 5 years or as per regulatory requirement.

6. Abbreviations

• IPC: In-Process Control
• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• SOP: Standard Operating Procedure

7. Documents

1. In-Process Control Record – Annexure-1
2. Batch Manufacturing Record (BMR)

8. References

• ICH Q8 – Pharmaceutical Development
• WHO GMP Guidelines for In-Process Controls

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: In-Process Control Record

Date	Time	Batch No.	Stage	Parameter	Observed Value	Specification	Checked By	Remarks
				pH		6.0–7.5
				Viscosity		5000–10000 cP
				Temperature		25±2°C
				Weight Variation		±5%

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
01/06/2022	1.0	Initial Release	New SOP	QA Head
02/06/2025	2.0	Detailed recording procedure and updated annexure format	Compliance Update	QA Head