data is generated and recorded for compliance and product quality verification.

3. Responsibilities

• Production Officer: Responsible for ensuring accurate recording of IPC parameters in real-time.
• QA Officer: Responsible for cross-verifying recorded IPC data against equipment logs, observations, and batch records.
• Production Supervisor: Reviews and signs off IPC records before submission to QA.

4. Accountability

The Head of Quality Assurance is accountable for implementation and oversight of the cross-verification process for IPC records.

5. Procedure

5.1 Identification of IPC Data

1. Identify IPC parameters such as volume, pH, temperature, vacuum, sealing integrity, etc., required for each product.
2. Refer to the approved BMR (Batch Manufacturing Record) and IPC checklist for each product batch.

5.2 Collection and Recording of IPC Data

1. Record IPC results immediately after each check in the IPC data sheet (Annexure-1).
2. Ensure entries are legible, signed, and dated by the responsible person.

5.3 Cross-Verification Steps by QA

1. Obtain completed IPC records from Production.
2. Compare recorded values with:
   • Equipment printouts/logs
   • Automated data logger output (if applicable)
   • Visual verification during line clearance or sampling
3. Mark any discrepancies in red ink and raise a deviation report (if required).
4. Verify calibration status of instruments used during IPC.

5.4 Data Review and Documentation

1. Review data for completeness, accuracy, consistency, and traceability.
2. Ensure changes/corrections are counter-signed with justification.
3. Summarize cross-verification outcome in IPC Verification Summary Log (Annexure-2).

5.5 Handling Discrepancies

1. QA shall initiate deviation report for critical or unexplained mismatches.
2. Perform root cause analysis and corrective actions as per deviation SOP.

5.6 Archival of Verified Data

1. After QA sign-off, all IPC records and verification logs shall be archived with the respective BMR.
2. Retention period shall follow the regulatory retention SOP (minimum 5 years).

6. Abbreviations

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

7. Documents

1. IPC Data Sheet – Annexure-1
2. IPC Verification Summary Log – Annexure-2
3. Deviation Report – Annexure-3 (if applicable)

8. References

• ICH Q10 – Pharmaceutical Quality System
• 21 CFR Part 211 – Current Good Manufacturing Practice
• WHO TRS 986 – Annex 2: GMP for Sterile Pharmaceutical Products

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: IPC Data Sheet

Date	Batch No.	Parameter	Observed Value	Recorded By
18/06/2025	INJ-5412	Filling Volume	1.00 mL	Ajay Nair

Annexure-2: IPC Verification Summary Log

Batch No.	Data Verified	Discrepancies Found	QA Reviewer	Date
INJ-5412	Yes	No	Sunita Reddy	19/06/2025

Annexure-3: Deviation Report

Deviation ID	Description	Root Cause	Corrective Action	Status
DEV-323	pH mismatch in IPC vs. data logger	Sensor drift	Recalibrate pH meter	Closed

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	New SOP	QA Head
18/06/2025	2.0	Updated with Annexures and real-time verification procedure	GMP Alignment	QA Head