the Analytical Method Development (AMD) department. This includes procurement, qualification, labelling, storage, usage, requalification, and destruction to ensure data integrity and regulatory compliance.

2. Scope

This SOP applies to all reference and working standards used for method validation, transfer, and stability studies conducted within the AMD department, including pharmacopoeial, certified, or in-house developed standards.

3. Responsibilities

• Analyst: Requests, uses, and records the usage of standards in the analytical worksheet.
• AMD Documentation Officer: Maintains logbooks for receipt, qualification, and requalification.
• QA Representative: Verifies documentation and compliance with SOP and regulatory guidelines.
• Stores Personnel: Assists in controlled storage and tracking of standard stock.

4. Accountability

The Head of AMD is accountable for ensuring compliance with procedures for handling, tracking, and using reference and working standards within the department.

5. Procedure

5.1 Procurement and Receipt

1. Reference standards shall be procured from pharmacopeial sources (e.g., USP, EP, BP) or certified manufacturers.
2. Working standards may be prepared in-house using qualified batches and compared with certified RS.
3. On receipt, verify the Certificate of Analysis (CoA), batch number, expiry, and manufacturer details.
4. Log receipt details in Reference Standard Register (Annexure-1).

5.2 Labelling and Identification

1. Each container must be labeled with the name, batch number, received date, expiry/re-test date, and storage conditions.
2. Labels must also include the unique RS/WS ID number for traceability.

5.3 Qualification and Approval

1. Perform identity, assay, and purity checks for in-house WS by comparing it against certified RS.
2. Prepare a Working Standard Qualification Report (Annexure-2) including raw data and comparison results.
3. Obtain approval from QA prior to use.

5.4 Storage and Inventory Control

1. Store standards in temperature-controlled refrigerators or desiccators based on label instructions.
2. Maintain an inventory log for RS and WS, updating it with each issuance (Annexure-3).
3. Conduct periodic checks to ensure standard integrity and prevent usage beyond expiry.

5.5 Usage and Documentation

1. Standards should be brought to room temperature before use and returned immediately after use.
2. Record quantity used, analyst name, date, and purpose in the Standard Usage Log (Annexure-4).
3. Ensure cumulative usage does not exceed predefined quantity thresholds.

5.6 Requalification and Expiry

1. Conduct requalification prior to re-test date by evaluating critical parameters.
2. If RS or WS fails requalification, immediately withdraw it from use and label as “Expired.”
3. Prepare Requalification Summary and submit to QA for final disposition.

5.7 Destruction and Disposal

1. Expired or failed standards should be destroyed under supervision as per hazardous waste disposal SOP.
2. Document destruction details in Annexure-5 and obtain QA approval.

6. Abbreviations

• RS: Reference Standard
• WS: Working Standard
• CoA: Certificate of Analysis
• QA: Quality Assurance

7. Documents

1. Reference Standard Register – Annexure-1
2. Working Standard Qualification Report – Annexure-2
3. Standard Inventory Log – Annexure-3
4. Standard Usage Log – Annexure-4
5. Destruction Record – Annexure-5

8. References

• ICH Q6A – Specifications: Test Procedures and Acceptance Criteria
• WHO Technical Report Series 992 – Good Practices for Pharmaceutical Quality Control Laboratories
• 21 CFR Part 211.84 – Testing and Approval of Components

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Nikita Sharma	Arun Mehta	Dr. Harshita Goyal
Designation	AMD Chemist	QA Reviewer	Head – AMD Department
Department	Analytical Method Development	Quality Assurance	Analytical Method Development

11. Annexures

Annexure-1: Reference Standard Register

RS ID	Name	Batch No.	Source	Received Date	Expiry	Status
RS-318-01	Metformin HCl	MTH/USP/2025	USP	20/05/2025	20/05/2026	Active

Annexure-2: WS Qualification Report

Includes assay results, identity confirmation, RS comparison, purity check, and approval record.

Annexure-3: Standard Inventory Log

Tracks stock balance, usage trend, and minimum re-order levels.

Annexure-4: Standard Usage Log

Date	Analyst	Purpose	Qty Used	Remaining	Remarks
25/05/2025	Amit R.	Assay Validation	50 mg	450 mg	Logged

Annexure-5: Destruction Record

Details of quantity destroyed, mode of destruction, witness signatures, and justification for disposal.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Expanded requalification and labeling guidelines	Annual SOP Review	Dr. Harshita Goyal
12/08/2022	1.0	Initial SOP Release	New SOP Implementation	QA Head