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