Standard Operating Procedure for Reference Standard Management

1) Purpose

This SOP outlines the procedures for the handling, storage, qualification, use, and disposal of reference standards to ensure their integrity, traceability, and compliance with regulatory requirements in pharmaceutical testing and analysis.

2) Scope

This SOP applies to all laboratory personnel involved in the procurement, receipt, handling, storage, qualification, and use of reference standards within the pharmaceutical facility.

3) Responsibilities

The Laboratory Manager or designated personnel are responsible for overseeing reference standard management procedures. Laboratory analysts and technicians are responsible for performing and documenting activities related to reference standards.

4) Procedure

4.1 Procurement and Receipt

1. Define and document criteria for selecting suppliers and purchasing reference standards based on purity, stability, and regulatory compliance.
2. Verify receipt of reference standards against purchase orders and certificates of analysis (CoA).

4.2 Handling and Storage

1. Handle reference standards carefully to avoid contamination, degradation, or cross-contamination.
2. Store reference standards under specified conditions (temperature, humidity) as per manufacturer’s recommendations or stability data.

4.3 Qualification and Calibration

1. Qualify reference standards upon receipt through analytical testing, comparing results against established acceptance criteria or pharmacopeial standards.
2. Calibrate analytical instruments using qualified reference standards to ensure accuracy and reliability of test results.

4.4 Use of Reference Standards

1. Document usage of reference standards including