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 batch/lot number, expiration date, and amount used.
2. Use reference standards only within their established shelf-life or expiration date and discard expired or degraded standards.

4.5 Disposal and Documentation

1. Dispose of reference standards following approved procedures, documenting disposal activities and reasons for disposal.
2. Maintain records of reference standard inventory, usage, qualification, and disposal in a controlled and traceable manner.

5) Abbreviations, if any

SOP: Standard Operating Procedure
CoA: Certificate of Analysis

6) Documents, if any

Reference Standard Qualification Protocols, Reference Standard Inventory Records, Disposal Records

7) Reference, if any

Regulatory guidelines such as ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, USP General Chapter 1085 Reference Standards and Materials, FDA Guidance for Industry: Analytical Procedures and Methods Validation

8) SOP Version

Version 1.0