verification, reaction monitoring, intermediate testing, filtration checks, drying confirmation, and milling or blending operations at the API manufacturing site.

3. Responsibilities

• Production/Process Chemists: Record all IPC data in approved formats and submit records for QA review.
• QA Officer/Executive: Reviews IPC records for completeness, accuracy, GMP compliance, and any discrepancies.
• QC Department: Provides analytical results for IPC sampling performed in the lab, if applicable.
• QA Documentation Cell: Maintains reviewed IPC records and tracks observations or trending data.

4. Accountability

The Head of QA is accountable for ensuring the integrity, traceability, and compliance of IPC records through timely and effective QA review processes.

5. Procedure

5.1 Types of IPC Records Reviewed

1. IPC records include:
   • pH checks during reaction stages
   • Moisture content during drying (LOD)
   • Filtration clarity and filter integrity
   • Intermediate identification and assay (TLC/HPLC)
   • Temperature or pressure logs
   • Sampling logs and retention samples

5.2 Record Collection and Submission

1. Production personnel must submit completed IPC records to QA daily or at stage completion.
2. All entries must be:
   • Legible, with black or blue ink
   • Initialed and dated by the performer
   • Crossed out with a single line in case of correction (no overwriting)
3. QA shall reject any record not complying with ALCOA+ principles.

5.3 QA Review Checklist

1. QA shall verify:
   • Correct batch number and stage name
   • Authorized signatory and date/time of activity
   • Limits/specifications as per BMR/BPR
   • Any deviation or OOT noted and escalated
2. Use IPC Record Review Checklist (Annexure-1).
3. If discrepancies are observed, a QA Observation Form shall be raised (Annexure-2).

5.4 Approval and Documentation

1. If records are found compliant, QA shall sign and date each page with a “Reviewed by QA” stamp.
2. Records shall be filed in the respective batch file maintained in QA archives.
3. Any analytical values received from QC shall be reconciled with production records before QA approval.

5.5 Trending and Monitoring

1. QA shall maintain a Monthly IPC Record Tracker (Annexure-3) to trend:
   • Number of IPCs reviewed
   • Non-compliance observed
   • Repeat observations across batches
2. This trending shall be used in the APQR and for planning training needs.

5.6 Deviations and Investigation

1. In case of critical or recurring documentation errors, QA shall initiate a deviation and conduct root cause analysis.
2. Based on impact, retraining or CAPA may be initiated.

6. Abbreviations

• IPC: In-Process Control
• QA: Quality Assurance
• BMR: Batch Manufacturing Record
• OOT: Out of Trend
• CAPA: Corrective and Preventive Action
• ALCOA+: Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available

7. Documents

1. IPC Record Review Checklist (Annexure-1)
2. QA Observation Form (Annexure-2)
3. Monthly IPC Record Tracker (Annexure-3)

8. References

• ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• 21 CFR Part 211 – Subpart F: Production and Process Controls
• EU GMP Guidelines – Part II

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 Record Review Checklist

Checkpoint	Compliant (Y/N)	Comments
Batch Number matches BMR	Y	–
Signatures & Date present	Y	–
Limits followed	Y	–

Annexure-2: QA Observation Form

Observation No.	Date	Observed By	Description	Action Taken
QA/OBS/2025/04	12/04/2025	Sunita Reddy	Missing IPC limits on pH record	Clarified and retrained

Annexure-3: Monthly IPC Record Tracker

Month	Total IPCs Reviewed	Observations Raised	Repeat Issues
March 2025	48	3	1

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP	New document	QA Head
14/04/2025	2.0	Added IPC tracker, observation form	Improved traceability	QA Head