Standard Operating Procedure for Destruction of Used IPC Samples in API Manufacturing

Department	API Manufacturing
SOP No.	SOP/API/106/2025
Supersedes	SOP/API/106/2022
Page No.	Page 1 of 10
Issue Date	13/04/2025
Effective Date	15/04/2025
Review Date	13/04/2026

1. Purpose

To define the procedure for safe, compliant, and documented destruction of In-Process Control (IPC) samples after testing and analysis are complete, ensuring traceability and adherence to regulatory requirements.

2. Scope

This SOP applies to all IPC samples (solid, semi-solid, liquid) collected and tested during API manufacturing processes and retained temporarily within QC labs or IPC stations.

3. Responsibilities

• QC Analyst: Identify and segregate used IPC samples, initiate destruction procedure, and record entries.
• QA Officer: Review destruction records and approve the destruction log before disposal.
• Production Chemist: Provide traceability reference (batch number, stage, sample type) to QC as needed.

4. Accountability

The QC Head is accountable for execution of destruction, while the QA Head is responsible for approval and oversight of sample destruction in accordance with GMP practices.

5. Procedure

5.1 Identification of Used IPC Samples

1. Upon completion of testing, segregate samples marked as “Used” or “Tested” and ready for disposal.
2. Ensure samples are no longer required for re-analysis, investigation, or training purposes.
3. Check if hold samples or retention samples are separate and not impacted by the destruction batch.

5.2 Documentation Prior to Destruction

1. Record details of used samples in the IPC Sample Destruction Logbook (Annexure-1).
2. Each entry should include:
   • Batch Number
   • Stage of Sampling
   • Sample Quantity
   • Date of Destruction
   • Reason for Destruction
3. QA shall verify and sign off before physical disposal of the sample.

5.3 Destruction Methods

1. Use the following destruction methods based on sample type:
   • Solid and Powdered Samples: Mix with inert absorbent material and dispose in non-recoverable containers, marked as pharmaceutical waste.
   • Liquid Samples: Neutralize if reactive, absorb into disposal granules or dispose through waste solvent drain as per SOP.
   • Semi-solid Samples: Absorb using disposal tissue/pads and discard as per solid waste disposal SOP.
2. All destroyed samples must be rendered non-recoverable and unidentifiable.

5.4 Disposal Coordination

1. Disposed samples shall be transferred to the designated Waste Collection Area.
2. Coordinate with EHS (Environment, Health & Safety) team or disposal vendor (if applicable) as per waste disposal SOP.
3. Maintain records of batch disposal along with sample disposal forms, signed by QC and QA.

5.5 Special Situations

1. For samples associated with OOS or Deviations, retain them until the investigation is closed.
2. Destruction for such samples must be reviewed with QA and investigation number should be referenced.

6. Abbreviations

• SOP: Standard Operating Procedure
• IPC: In-Process Control
• QC: Quality Control
• QA: Quality Assurance
• OOS: Out of Specification
• EHS: Environment, Health & Safety

7. Documents

1. IPC Sample Destruction Logbook (Annexure-1)
2. Waste Disposal Record (As per Waste Management SOP)
3. Investigation Closure Summary (if applicable)

8. References

• ICH Q7 – GMP Guide for Active Pharmaceutical Ingredients
• 21 CFR Part 211 – US FDA cGMP
• WHO TRS 986 – GMP Guidelines
• Company SOP on Waste Disposal

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 Destruction Logbook

Date	Batch No.	Stage	Sample Qty	Destroyed By	Verified By (QA)	Remarks
13/04/2025	API-20250413	Drying	10 g	Ravi Kumar	QA Officer	Complies

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP Release	Compliance	QA Head
13/04/2025	2.0	Added coordination with EHS and expanded destruction methods	Audit Compliance	QA Head