Standard Operating Procedure for Preparing Lyophilized Formulations for Reconstitution

1) Purpose

This SOP outlines the procedure for preparing lyophilized formulations that are intended to be reconstituted with a diluent before administration, ensuring the product remains stable, safe, and effective upon reconstitution.

2) Scope

This SOP applies to formulation scientists, production operators, and QA personnel involved in the preparation of lyophilized formulations for reconstitution, such as vaccines, monoclonal antibodies, and other injectable products.

3) Responsibilities

• Formulation Scientists: Responsible for developing the lyophilized formulation that is stable upon reconstitution.
• Operators: Responsible for the preparation and lyophilization of the formulation as outlined in the Batch Manufacturing Record (BMR).
• QA: Responsible for verifying that the formulation meets specifications after reconstitution and ensuring proper documentation.

4) Procedure

4.1 Preparation of Formulation for Lyophilization

4.1.1 Equipment Setup

• 4.1.1.1 Ensure that all equipment (e.g., mixers, filtration systems) is cleaned, sanitized, and calibrated before use.
• 4.1.1.2 Prepare sterile containers for the formulation and maintain aseptic conditions throughout the process.

4.1.2 Formulation Preparation

• 4.1.2.1 Weigh the required active ingredient(s) and excipients using a calibrated balance according to the BMR.
• 4.1.2.2 Dissolve the active ingredient in a suitable buffer or solvent (e.g., saline, WFI) and stir until fully dissolved.
• 4.1.2.3 Add excipients, stabilizers, or cryoprotectants if necessary,