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