received in the QC laboratory, including but not limited to raw materials, intermediates, in-process samples, finished APIs, packaging materials, cleaning samples, and stability samples.

3. Responsibilities

• QC Analyst: Responsible for entering sample details, updating status, and ensuring traceability throughout the testing cycle.
• QC Coordinator: Assign laboratory numbers and maintain the sample receipt and tracking log.
• QC Head: Ensure implementation and periodic review of the sample numbering and tracking system.

4. Accountability

The Quality Control Head is accountable for ensuring that all samples are tracked and identified in compliance with regulatory and internal documentation standards.

5. Procedure

5.1 Sample Receipt

1. All samples must be submitted with a duly filled Sample Intimation Form (SIF) or online request through the LIMS.
2. QC Coordinator checks the following upon receipt:
   • Sample condition and integrity
   • Proper labeling and packaging
   • Sample type and associated batch information
3. Samples that fail preliminary checks must be recorded and returned to the originator with justification.

5.2 Laboratory Number Assignment

1. A unique laboratory number shall be assigned sequentially using the format: QC/YY/XXXX where:
   • QC = Quality Control
   • YY = Last two digits of the calendar year
   • XXXX = Serial number starting from 0001 every year
2. Different types of samples may include additional suffixes:
   • RM: Raw Material (e.g., QC/25/0042-RM)
   • API: Finished API sample (e.g., QC/25/0045-API)
   • IPC: In-Process Control (e.g., QC/25/0051-IPC)
3. All laboratory numbers must be recorded in the Laboratory Sample Receipt Logbook (Annexure-1).

5.3 Sample Labeling

1. Each received sample shall be labeled with:
   • Lab number
   • Sample name and code
   • Batch number
   • Date of receipt
   • Storage condition (if applicable)
2. Ensure that labels are clear, permanent, and affixed securely on each sample container.

5.4 Sample Distribution and Tracking

1. QC Coordinator distributes the sample to the concerned analyst along with the SIF and lab number details.
2. Analyst updates the Sample Tracking Sheet (Annexure-2) with:
   • Date of testing initiation
   • Testing completion date
   • Analyst initials
   • Instrument ID used
3. Any delays or hold status must be documented with reason and approved by the QC Head.

5.5 Result Entry and Review

1. On completion of testing, analysts shall enter results in the analytical worksheet or LIMS, linking them with the assigned lab number.
2. The reviewer shall cross-check test results, raw data, and lab number entries for consistency.
3. Any discrepancy in sample identification or test results shall be investigated and logged.

5.6 Sample Retention and Disposal

1. Retain a portion of the sample as per SOP for control and retesting purposes.
2. Label control samples with a reference tag including the lab number.
3. Dispose of excess or expired samples as per the Sample Disposal SOP.

5.7 Audits and Traceability

1. QA may periodically review sample tracking logs for traceability and compliance.
2. All lab numbers must be traceable back to:
   • Sample origin
   • Batch records
   • Test results and CoA

6. Abbreviations

• QC: Quality Control
• API: Active Pharmaceutical Ingredient
• IPC: In-Process Control
• SIF: Sample Intimation Form
• LIMS: Laboratory Information Management System

7. Documents

1. Laboratory Sample Receipt Logbook (Annexure-1)
2. Sample Tracking Sheet (Annexure-2)
3. Sample Intimation Form

8. References

• 21 CFR Part 211 – Subpart I: Laboratory Controls
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• WHO TRS No. 1019 – Annex 4

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Laboratory Sample Receipt Logbook

Date	Lab No.	Sample Type	Batch No.	Received From	QC Coordinator
14/04/2025	QC/25/0123-API	API	BATCH1234	Production	Sunita Reddy

Annexure-2: Sample Tracking Sheet

Lab No.	Analyst	Date of Issue	Date of Completion	Instrument ID	Remarks
QC/25/0123-API	Rajesh Kumar	14/04/2025	15/04/2025	HPLC-03	NA

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP release	New system implementation	QA Head
14/04/2025	2.0	Included LIMS workflow and suffix coding	Standardization	QA Head