Procedure for Assay Testing of Active Pharmaceutical Ingredient (API)

1) Purpose

The purpose of this SOP is to outline the procedure for conducting assay testing on Active Pharmaceutical Ingredients (APIs) to ensure their potency and quality meet specified standards.

2) Scope

This SOP applies to all APIs used in pharmaceutical manufacturing within the facility that require assay testing as per regulatory requirements.

3) Responsibilities

Quality Control (QC) Department: Responsible for performing assay testing and ensuring compliance with this SOP.
Production Department: Responsible for providing API samples and supporting QC during testing.

4) Procedure

4.1 Equipment Preparation:
    4.1.1 Calibrate analytical balances and other equipment according to validated procedures.
    4.1.2 Ensure all necessary reagents, solvents, and standards are prepared and labeled correctly.
    4.1.3 Validate the suitability of equipment and instruments for assay testing.

4.2 Sample Handling and Preparation:
    4.2.1 Obtain representative samples of the API from the production department or quarantine area.
    4.2.2 Ensure samples are properly identified, labeled, and stored under appropriate conditions.
    4.2.3 Prepare sample solutions or suspensions as per specified methods and dilutions if necessary.

4.3 Assay Testing Procedure:
    4.3.1 Perform assay testing using validated analytical methods, such as HPLC, UV-Vis spectrophotometry, or titration.
    4.3.2 Analyze sample solutions against appropriate standards