at the facility.

3. Responsibilities

• QC Analyst: Perform sample reconciliation after IPC testing, document remaining quantity, and coordinate with QA for disposal.
• QA Officer: Verify reconciliation entries, approve final disposition of samples, and ensure retention or destruction as per policy.
• Production Chemist: Provide batch context and sampling log to assist reconciliation process.

4. Accountability

The QC Head is accountable for accurate documentation of IPC sample reconciliation. The QA Head is responsible for ensuring compliance and proper closure of sample usage logs.

5. Procedure

5.1 Sample Reconciliation Overview

1. All IPC samples collected for testing shall be labeled, logged, and stored securely in the designated IPC testing area.
2. After analysis, the remaining sample shall be reconciled and either:
   • Archived temporarily for investigation (if required)
   • Disposed of per waste management SOP

5.2 Documentation of Sample Usage

1. QC Analyst shall record the following in the IPC Sample Reconciliation Logbook (Annexure-1):
   • Date of sampling
   • Batch number
   • Initial sample quantity
   • Quantity used
   • Balance quantity
   • Disposition status
2. Any sample remaining after testing shall be labeled “Used IPC Sample – For Disposal” or “Retain for Investigation.”

5.3 Review and Verification

1. QA Officer shall:
   • Verify reconciliation data with original sample label and testing record
   • Check for consistency in quantity and status of each sample
   • Sign-off in the reconciliation logbook with comments
2. Discrepancies in quantity used, sample not found, or unlabeled vials must be documented as a deviation.

5.4 Sample Disposal

1. Destruction of used samples shall follow SOP/API/106/2025 for IPC sample disposal.
2. Record the destruction date and QA approval in the IPC Destruction Log (cross-referenced to reconciliation log).

5.5 Retention Samples

1. If IPC samples are to be retained for investigation or trending:
   • Store them in a segregated labeled container within QC lab
   • Label must indicate retention reason, retention period, and QA authorization
2. QA shall track and authorize final disposal of retained samples once no longer required.

6. Abbreviations

• IPC: In-Process Control
• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• cGMP: Current Good Manufacturing Practice

7. Documents

1. IPC Sample Reconciliation Logbook (Annexure-1)
2. IPC Sample Destruction Log
3. Deviation Form (if applicable)

8. References

• ICH Q7 – GMP for Active Pharmaceutical Ingredients
• 21 CFR Part 211 – US FDA cGMP
• 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: IPC Sample Reconciliation Logbook

Date	Batch No.	Sample Type	Qty Collected	Qty Used	Balance	Disposition	QA Verified
13/04/2025	API-20250413	LOD Test	10 g	2 g	8 g	Disposed	Yes

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Issue	Compliance Requirement	QA Head
13/04/2025	2.0	Added retention sample procedure and disposal tracking	Audit Observation	QA Head