accountability, and regulatory compliance.

2. Scope

This SOP applies to all research, validation, and stability samples processed in the AMD department, including samples for method development, method transfer, and method verification exercises.

3. Responsibilities

• Analytical Chemists: Ensure proper labeling, logging, and storage of samples.
• Documentation Officer: Maintain electronic and physical records of sample movement.
• QA Department: Audit sample traceability and document control.
• AMD Head: Ensure effective implementation of the SOP and training of personnel.

4. Accountability

The AMD Head is accountable for ensuring that all samples are properly tracked and documented from receipt to disposal, including compliance with data integrity standards.

5. Procedure

5.1 Sample Receipt

1. Upon receipt, inspect the sample condition and quantity against accompanying documents (e.g., sample request form).
2. Assign a unique Sample ID using the format: AMD-YY-XXX (e.g., AMD-25-045).
3. Record the sample in the Sample Receipt Logbook (Annexure-1) and in the LIMS if available.
4. Label the sample container with the assigned Sample ID using a waterproof label.

5.2 Sample Logging and Allocation

1. Log the sample details in the Sample Movement Register (Annexure-2), indicating assigned analyst and test plan.
2. Include relevant metadata: date received, test type, batch number, storage condition, and reference document.
3. Allocate sample portions for multiple testing parameters, if required (e.g., Assay, Dissolution, Impurity).

5.3 Sample Storage and Segregation

• Store samples in designated racks or refrigerators/freezers based on storage conditions mentioned in the protocol.
• Maintain segregation of stability samples, development samples, and validation samples using color-coded labels.

5.4 Sample Processing

1. Update the Sample Movement Register after each stage of processing (e.g., weighing, dilution, testing).
2. Link raw data (chromatograms, balance logs) to Sample ID for traceability.

5.5 Sample Disposal

1. Dispose of samples post-analysis as per SOP/QA/042/2023 on Sample Disposal.
2. Record the disposal date and method in the Sample Disposal Log (Annexure-3).
3. QA to perform monthly reconciliation of received vs. disposed samples.

5.6 Audit Trail and Data Integrity

• All sample tracking activities must be logged with timestamps and initials.
• Maintain both soft and hard copies of all sample logs and link with analytical data sets.
• Use only validated LIMS or tracking software if digital records are maintained.

6. Abbreviations

• AMD: Analytical Method Development
• LIMS: Laboratory Information Management System
• QA: Quality Assurance

7. Documents

1. Annexure-1: Sample Receipt Logbook
2. Annexure-2: Sample Movement Register
3. Annexure-3: Sample Disposal Log

8. References

• ICH Q9 – Quality Risk Management
• WHO TRS 1019 – Data Integrity Guidance
• 21 CFR Part 211 – Good Manufacturing Practice

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Devanshi Patel	Rajesh Sharma	Dr. Amit Trivedi
Designation	Analytical Chemist	QA Officer	Head – AMD
Department	Analytical Method Development	Quality Assurance	Analytical Method Development

11. Annexures

Annexure-1: Sample Receipt Logbook

Sample ID	Date	Product Name	Batch No.	Received By
AMD-25-045	01/06/2025	Ibuprofen 200mg	IBF2025B12	Devanshi Patel

Annexure-2: Sample Movement Register

Sample ID	Analyst	Activity	Date	Signature
AMD-25-045	Devanshi Patel	Weighing	02/06/2025	DP

Annexure-3: Sample Disposal Log

Sample ID	Disposal Method	Date	Disposed By
AMD-25-045	Incineration	05/06/2025	QA Officer

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Integrated LIMS tracking and digital log references	Periodic review	Dr. Amit Trivedi
11/05/2022	1.0	Initial issue	New SOP	QA Head