Standard Operating Procedure for Laboratory Reagent and Solution Preparation

1) Purpose

This SOP outlines the procedures for the preparation, labeling, and documentation of laboratory reagents and solutions to ensure accuracy, reliability, and traceability in pharmaceutical testing and analysis.

2) Scope

This SOP applies to all laboratory personnel involved in the preparation, storage, and use of reagents and solutions within the pharmaceutical facility, ensuring compliance with regulatory requirements and quality standards.

3) Responsibilities

The Laboratory Manager or designated personnel are responsible for overseeing reagent and solution preparation procedures. Laboratory technicians are responsible for performing and documenting preparation activities.

4) Procedure

4.1 Reagent and Solution Formulation

1. Review and follow approved formulas, methods, or pharmacopoeial monographs for reagent and solution preparation.
2. Ensure availability of required raw materials, solvents, and reference standards with appropriate documentation of their quality.

4.2 Preparation Process

1. Label containers with unique identifiers, including reagent name, concentration, preparation date, and expiration date.
2. Weigh or measure components accurately using calibrated instruments and follow specific mixing or dissolution procedures.

4.3 Quality Control Checks

1. Perform quality control checks such as pH measurement, specific gravity, visual inspection, and analytical testing as required.
2. Record all test results and verify compliance with predetermined specifications or acceptance criteria.

4.4 Documentation and Labeling

1. Document all preparation activities including batch records, calculations, deviations, and adjustments made during preparation.
2. Label prepared reagents and solutions clearly with necessary information and store them appropriately based on stability and usage requirements.

4.5 Storage and Stability

1. Store prepared reagents and solutions under conditions specified in the procedure to maintain stability and prevent degradation.
2. Monitor storage conditions regularly and establish expiration dates based on stability studies or manufacturer recommendations.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

Reagent and Solution Preparation Formulas, Batch Records, Quality Control Test Results, Stability Study Reports

7) Reference, if any

Regulatory guidelines such as USP General Chapter 797 Pharmaceutical Compounding – Sterile Preparations, FDA Guidance for Industry: Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, ICH Q2(R1) Validation of Analytical Procedures: Text and Methodology

8) SOP Version

Version 1.0