laboratory. The aim is to ensure regulatory compliance, avoid inadvertent use, and minimize laboratory contamination risk.

2. Scope

This procedure is applicable to all expired or soon-to-expire reference standards, working standards, certified reference materials, and impurity standards stored and used in the AMD laboratory.

3. Responsibilities

• AMD Analyst: Notifies the expiry of reference standards and segregates them from usable stock.
• Standard Coordinator: Maintains the Reference Standard Register and initiates disposal documentation.
• QA Representative: Verifies disposal activities, reviews logbooks, and ensures compliance with GMP regulations.

4. Accountability

The Head of Analytical Method Development is accountable for ensuring that no expired reference standards are used for any analytical activity and that disposal is carried out according to environmental safety and regulatory norms.

5. Procedure

5.1 Identification of Expired Materials

1. Maintain a Reference Standard Register (Annexure-1) listing all standards with receipt date, expiry date, lot number, and quantity.
2. Generate a monthly alert for standards nearing expiration using the inventory system or manual calendar tracking.
3. Label expired standards with “EXPIRED – DO NOT USE” sticker in red ink and transfer them to the expired standards locker.

5.2 Segregation and Documentation

1. Prepare a list of expired items using Annexure-2 format and include lot number, container ID, expiry date, and remaining quantity.
2. Cross-verify the physical stock with the electronic inventory or register.
3. QA shall verify the list and affix initials confirming segregation.

5.3 Disposal Authorization

1. Initiate the “Expired Standard Disposal Form” and send it to QA for approval.
2. Obtain sign-off from AMD Head and QA Head before proceeding to disposal.
3. Record approval details in Annexure-3.

5.4 Disposal Method

1. Transfer expired standards to the waste storage area under supervision.
2. Disposal of solids should be done via incineration or high-temperature furnace depending on classification (e.g., carcinogens, teratogens).
3. Disposal of liquids should be coordinated with the EHS department and follow local hazardous waste management guidelines.
4. Document the disposal date, method, location, and disposal agency in the Reference Standard Disposal Log (Annexure-3).

5.5 Handling of Recalled or Invalidated Standards

1. In case of recall by vendor or manufacturer, label the affected lots as “RECALLED – DO NOT USE”.
2. Quarantine and follow the same segregation, authorization, and disposal procedures as expired materials.
3. Update the register with “RECALLED” status and initiate CAPA where applicable.

6. Abbreviations

• AMD: Analytical Method Development
• QA: Quality Assurance
• CAPA: Corrective and Preventive Action
• EHS: Environment, Health and Safety

7. Documents

1. Reference Standard Register – Annexure-1
2. Expired Standard Summary Sheet – Annexure-2
3. Reference Standard Disposal Log – Annexure-3

8. References

• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• WHO TRS 996 Annex 2 – Good Practices for Pharmaceutical Quality Control Laboratories
• 21 CFR Part 211.84 – Testing and Approval or Rejection of Components
• Company Environmental Safety Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Shreya Sharma	Arvind Menon	Dr. Harshita Goyal
Designation	Standard Coordinator	QA Reviewer	Head – Analytical Method Development
Department	Analytical Method Development	Quality Assurance	Analytical Method Development

11. Annexures

Annexure-1: Reference Standard Register

Standard Name	Lot No.	Expiry Date	Quantity	Status
Ibuprofen RS	IBRS-045	28/05/2025	3.5 g	Expired

Annexure-2: Expired Standard Summary Sheet

Standard Name	Lot No.	Expiry Date	Quantity	Verified By (QA)
Losartan WS	LSWS-021	15/04/2025	2.1 g	R. Mehta

Annexure-3: Reference Standard Disposal Log

Standard	Lot	Disposal Date	Method	Disposed By	QA Verified
Omeprazole RS	OMRS-009	01/06/2025	Incineration	M. Iqbal	P. Nair

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Added handling of recalled standards and EHS guidelines	Annual Update	Dr. Harshita Goyal
01/07/2022	1.0	Initial release of SOP	New Document	QA Head