Reference Standard Management in Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for managing reference standards used in analytical method development, ensuring their integrity, traceability, and suitability for use.

2) Scope

This SOP applies to all personnel involved in reference standard management for analytical method development projects within the analytical development department.

3) Responsibilities

The purpose of this SOP is to define the roles and responsibilities of all personnel involved in reference standard management.

4) Procedure

1. Procurement and Receipt:
   1. Define requirements for reference standards based on method development needs.
   2. Select appropriate suppliers and procure reference standards with necessary documentation (Certificate of Analysis, MSDS, etc.).
   3. Verify receipt against purchase orders and ensure proper handling during transport.
2. Storage and Handling:
   1. Establish storage conditions (temperature, humidity, light exposure) based on stability data and regulatory requirements.
   2. Label reference standards clearly with identification, expiration dates, and storage conditions.
   3. Implement inventory management practices to track usage, storage locations, and stock levels.
3. Usage and Preparation:
   1. Document usage of reference standards, including withdrawals and returns.
   2. Prepare reference standards as per documented procedures, ensuring accuracy and traceability.
4. Periodic Review and Requalification:
   1. Establish a periodic review schedule for reference standards based on stability data and usage history.
   2. Requalify reference standards through analytical testing to verify continued suitability for use.
5. Disposal:
   1. Define procedures for disposal of expired or unused reference standards.
   2. Ensure compliance with environmental regulations and safety protocols during disposal.
6. Documentation and Records:
   1. Maintain accurate documentation of reference standard procurement, usage, and disposal.
   2. Keep records of qualification and requalification activities, including analytical results and review outcomes.

5) Abbreviations, if any

The purpose of this SOP is to define the commonly used abbreviations related to reference standard management in analytical method development.

6) Documents, if any

List of documents to be maintained related to this SOP:

• Reference Standard Inventory
• Qualification and Requalification Records
• Disposal Records
• Documentation of Usage and Preparation

7) Reference, if any

Regulatory guidelines related to this SOP include:

• ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• USP General Chapter Reference Standards

8) SOP Version

Version 1.0