complaints.

3. Responsibilities

• QC Analyst: Collect and label investigation samples, record relevant details, and store under specified conditions.
• QA Officer: Review sample retention entries, verify storage conditions, and authorize release or destruction post-investigation.
• Production Chemist: Identify and notify potential sample preservation needs during batch processing.

4. Accountability

The QA Head is accountable for ensuring proper sample retention practices, documentation, and release/disposal authorization after investigation closure.

5. Procedure

5.1 Sample Collection for Investigation

1. Samples to be preserved may arise from:
   • Out-of-Specification (OOS) or Out-of-Trend (OOT) observations
   • Processing deviations
   • Customer complaint investigation
   • Visual abnormalities or inconsistent results
2. QC Analyst or Production shall collect 10–25 g (solid) or 10–25 mL (liquid) samples, depending on investigation type and analytical requirements.

5.2 Labeling Requirements

1. Each preserved sample shall bear a label clearly mentioning:
   • “Sample for Investigation” (Red label)
   • Batch No. and Sample Type
   • Date of Collection
   • Reason for Preservation (e.g., OOS, Deviation No., Complaint ID)
   • Stored By and Verified By

5.3 Documentation

1. Record the preserved sample details in the Investigation Sample Logbook (Annexure-1), including:
   • Investigation trigger (Deviation/OOS ID)
   • Storage location and conditions
   • Expected retention duration
2. Update the status in the deviation/investigation file, and assign QA tracking number.

5.4 Storage Conditions

1. Store preserved samples in a dedicated investigation cabinet with restricted access and temperature monitoring (if applicable).
2. Conditions:
   • Solids: Room temperature (15–25°C) unless otherwise specified
   • Liquids: Cool conditions (2–8°C) if stability is a concern

5.5 Sample Review and Disposal

1. Upon completion of investigation:
   • QA will assess whether the sample is required for re-analysis or retained further.
   • If no longer required, sample shall be destroyed following SOP/API/106/2025.
2. Destruction shall be documented in the Investigation Sample Disposal Record (Annexure-2).

6. Abbreviations

• IPC: In-Process Control
• OOS: Out of Specification
• OOT: Out of Trend
• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control

7. Documents

1. Investigation Sample Logbook (Annexure-1)
2. Investigation Sample Disposal Record (Annexure-2)
3. Deviation Report / OOS Report

8. References

• ICH Q7 – GMP for Active Pharmaceutical Ingredients
• 21 CFR Part 211 – US FDA cGMP Guidelines
• WHO TRS 986 – Annex 2: GMP for APIs

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Investigation Sample Logbook

Date	Batch No.	Sample Type	Reason	Stored By	Storage Location	QA Verified
13/04/2025	API-20250413	Drying Intermediate	OOT in LOD	Sunita Reddy	Cabinet-02	Yes

Annexure-2: Investigation Sample Disposal Record

Date	Sample ID	Batch No.	Disposed By	Witnessed By	Disposal Method
20/04/2025	INV-2025-004	API-20250413	Ravi Kumar	QA Officer	Incineration

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	New SOP	QA Head
13/04/2025	2.0	Added Annexures and disposal documentation	Audit Recommendation	QA Head