Standard Operating Procedure for Reconstitution Testing of Lyophilized Products

1) Purpose

This SOP describes the steps to be taken during the reconstitution testing of lyophilized products to verify that the product dissolves as expected and retains its potency and stability after reconstitution.

2) Scope

This SOP applies to all laboratory personnel responsible for reconstituting lyophilized products and ensuring product quality post-reconstitution.

3) Responsibilities

• Laboratory Personnel: Responsible for conducting the reconstitution testing according to the Batch Manufacturing Record (BMR).
• QA Personnel: Responsible for verifying that reconstitution results meet product specifications.

4) Procedure

4.1 Reconstitution Process

4.1.1 Diluent Selection

• 4.1.1.1 Use the appropriate diluent as specified in the BMR for reconstituting the lyophilized product.
• 4.1.1.2 Add the diluent to the vial containing the lyophilized product and gently swirl to dissolve. Do not shake vigorously to avoid foaming or denaturation.

4.1.2 Time to Dissolve

• 4.1.2.1 Record the time it takes for the product to fully dissolve. The dissolution time must be within the limits defined in the BMR.

4.1.3 Clarity Testing

• 4.1.3.1 After reconstitution, inspect the solution for clarity. The solution must be clear and free of particulates unless otherwise specified in the product’s standards.

4.2 Documentation

All results from reconstitution testing, including dissolution time and clarity, must be documented in