Standard Operating Procedure for Reconstitution Testing of Lyophilized Products

1) Purpose

This SOP outlines the procedure for testing the reconstitution of lyophilized products to ensure that the product dissolves fully and retains its intended potency and stability after reconstitution.

2) Scope

This SOP applies to laboratory personnel responsible for conducting reconstitution testing and verifying product quality after the lyophilization process.

3) Responsibilities

• Laboratory Personnel: Responsible for performing reconstitution tests according to the Batch Manufacturing Record (BMR).
• QA Personnel: Responsible for verifying that reconstitution tests meet product specifications and regulatory guidelines.

4) Procedure

4.1 Reconstitution Protocol

4.1.1 Preparation

• 4.1.1.1 Ensure that the appropriate diluent (as specified in the BMR) is used for reconstituting the lyophilized product.
• 4.1.1.2 Use the specified volume of diluent and dissolve the lyophilized product by gently swirling or inverting the vial, avoiding vigorous shaking.

4.2 Testing Parameters

4.2.1 Time to Dissolve

• 4.2.1.1 Record the time it takes for the lyophilized product to completely dissolve in the diluent. The product should dissolve within the time limit specified in the BMR.

4.2.2 Visual Clarity

• 4.2.2.1 Inspect the reconstituted solution for clarity. It should be free of particulates or turbidity unless otherwise specified in the product specifications.

4.2.3 Potency Testing

• 4.2.3.1 Conduct potency assays to ensure the product retains its therapeutic efficacy after