standards (RS) and secondary working standards (WS) used in the Analytical Method Development (AMD) department.

2. Scope

This SOP applies to all AMD personnel responsible for procuring, qualifying, using, and maintaining records related to reference and working standards within the pharmaceutical analytical laboratory.

3. Responsibilities

• Analyst: Handles and maintains the integrity of RS and WS during analytical activities.
• AMD Supervisor: Ensures compliance with qualification and documentation procedures.
• QA Department: Verifies and audits standard qualification activities.

4. Accountability

The Head of Analytical Method Development is accountable for ensuring the proper qualification, usage, and control of all standards used in analytical testing and method development.

5. Procedure

5.1 Procurement of Reference Standards

1. Purchase RS from recognized sources such as USP, EP, BP, IP, or WHO reference standards.
2. Verify certificate of analysis (CoA), lot number, and expiry date upon receipt.
3. Log the RS in the Reference Standard Register (Annexure-1).

5.2 Qualification of Working Standards

1. Select RS for the qualification of WS.
2. Perform identity, assay, and impurity profiling on three replicate preparations.
3. Calculate assigned potency of WS based on assay result relative to RS.
4. Document all qualification results and assign a unique WS code (Annexure-2).

5.3 Labeling

1. Affix label to RS and WS containers indicating:
   • Name of substance
   • Assigned potency (for WS)
   • Batch/Lot number
   • Qualification date
   • Expiry date
   • Storage condition

5.4 Storage

1. Store standards in designated desiccators or refrigerators as per CoA/storage conditions.
2. Restrict access to authorized personnel only.
3. Maintain temperature log for the storage area.

5.5 Usage

1. Withdraw minimal quantity required using a clean spatula or scoop.
2. Record each usage in the WS/RS usage log (Annexure-3).
3. Avoid contamination during withdrawal; do not return excess material to the original container.

5.6 Requalification and Expiry

1. Assign requalification period for WS (e.g., 6 months) based on stability data.
2. Before expiry, evaluate WS potency and assign new qualification if applicable.
3. Destroy expired standards as per the destruction SOP and document appropriately.

6. Abbreviations

• RS: Reference Standard
• WS: Working Standard
• AMD: Analytical Method Development
• CoA: Certificate of Analysis

7. Documents

1. Reference Standard Register – Annexure-1
2. Working Standard Qualification Record – Annexure-2
3. RS/WS Usage Log – Annexure-3

8. References

• ICH Q6A – Specifications: Test Procedures and Acceptance Criteria
• USP General Chapter <1058> Analytical Instrument Qualification
• WHO Guidelines on Quality Control of Pharmaceutical Products

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Ananya Tripathi	Sachin Nanda	Dr. Harshita Goyal
Designation	AMD Analyst	QA Reviewer	Head – Analytical Method Development
Department	Analytical Method Development	Quality Assurance	Analytical Method Development

11. Annexures

Annexure-1: Reference Standard Register

RS Code	Name	Source	Lot No.	Expiry	Storage
RS-398-01	Paracetamol	USP	U1234	12/2026	2–8°C

Annexure-2: Working Standard Qualification Record

Includes detailed assay results, comparison with RS, chromatograms, calculation of assigned potency, analyst and reviewer initials.

Annexure-3: RS/WS Usage Log

Date	Standard	Used For	Qty	Used By	Remarks
28/05/2025	WS-Paracetamol	Assay Validation	50 mg	Ananya	—

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Updated WS requalification and labeling format	Annual Review	Dr. Harshita Goyal
15/05/2022	1.0	Initial Issue	New SOP	QA Head