QC personnel responsible for the initial handling of samples in the QC lab. It includes procedures for visual inspection, coding, sample labeling, logbook entry, and storage prior to testing.

3. Responsibilities

• QC Chemist: Receive the sample, assign sample number, label the sample, and make logbook entries.
• QC Executive: Review the sample information for completeness and correctness, and initiate analysis as per priority.
• QA Officer: Verify sample accountability during audit or review processes.

4. Accountability

The QC Head is accountable for ensuring that sample receipt and login activities are documented accurately and performed in accordance with regulatory and internal requirements.

5. Procedure

5.1 Sample Receipt from Various Sources

1. QC receives samples from:
   • Raw Material Store (for raw material testing)
   • Production (in-process/intermediate/final API)
   • Stability chamber (for stability studies)
   • External vendors or complaint samples (if applicable)

5.2 Preliminary Check

1. Upon receiving the sample, QC shall verify:
   • Label is clear and legible
   • Container is intact and sealed
   • Sample is sufficient in quantity for all required tests
   • Test request form (TRF) is attached and filled

5.3 Sample Number Assignment

1. Assign a unique QC Sample Number in the following format:
   QC/YY/MM/XXX (e.g., QC/25/04/102)
   • YY: Year
   • MM: Month
   • XXX: Serial number of the sample received that month

5.4 Sample Labeling

1. Affix the QC label with:
   • QC Sample Number
   • Date of Receipt
   • Batch Number
   • Sample Description (e.g., RM, IPC, API)
   • Storage condition (if applicable)
2. Use red labels for OOS, yellow for OOT, and green for general samples.

5.5 Entry into Sample Login Register

1. Enter all sample details in the Sample Login Register (Annexure-1), including:
   • Sample Number
   • Source
   • Batch Number
   • Date and Time of Receipt
   • Type of Analysis
   • Condition at Receipt

5.6 Sample Storage and Handover

1. Store samples under appropriate conditions until they are taken for analysis (e.g., desiccator, refrigerator, ambient shelf).
2. Hand over the sample with TRF to the designated analyst for testing as per schedule.

5.7 Sample Discrepancy Management

1. If any discrepancy is observed (e.g., leakage, labeling issue, missing TRF), inform the sender and record details in the Sample Discrepancy Logbook.
2. Do not proceed with login until resolved and documented.

6. Abbreviations

• QC: Quality Control
• QA: Quality Assurance
• API: Active Pharmaceutical Ingredient
• TRF: Test Request Form
• IPC: In-Process Control

7. Documents

1. Sample Login Register (Annexure-1)
2. Sample Discrepancy Logbook
3. Test Request Form

8. References

• ICH Q7 – GMP for APIs
• 21 CFR Part 211 – US FDA GMP Requirements
• 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: Sample Login Register

Sample No.	Date	Batch No.	Sample Type	Source	Received By	Condition	Remarks
QC/25/04/102	13/04/2025	API-20250413	IPC	Production	Ravi Kumar	Good	–

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Issue	New SOP	QA Head
13/04/2025	2.0	Added color label system and discrepancy handling	Audit Observation	QA Head