SOP for Assay Testing of Active Pharmaceutical Ingredient (API)

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.

See also SOP for Dissolution 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 and controls to determine API concentration or potency.
    4.3.3 Record raw data including chromatograms, spectra, or titration curves as required.
    4.3.4 Perform calculations to determine the percentage of API present in the sample based on standard curves or reference standards.

4.4 Calculation and Interpretation:
    4.4.1 Calculate the assay results based on the formula specified in the analytical method.
    4.4.2 Compare the assay results against acceptance criteria specified in pharmacopeial standards or internal specifications.
    4.4.3 Document and investigate any deviations from expected assay results, taking corrective actions if necessary.

4.5 Acceptance Criteria:
4.5.1 API assay results should meet the specified potency or concentration range for the product.
4.5.2 Ensure all analytical controls and standards demonstrate appropriate responses within established limits.

4.6 Documentation:
    4.6.1 Record all assay testing procedures, results, and observations in the Assay Testing Record.
    4.6.2 Maintain detailed records of sample preparation, testing conditions, and any deviations encountered.
    4.6.3 Review and approve the documentation by QC Manager.

5) Abbreviations, if any

QC: Quality Control
API: Active Pharmaceutical Ingredient
HPLC: High Performance Liquid Chromatography
UV-Vis: Ultraviolet-Visible Spectroscopy

6) Documents, if any

Assay Testing Record
Method Validation Report for Assay Testing
Sampling Plan Document

7) Reference, if any

USP General Chapter <711> – Dissolution
Pharmacopeial standards for Assay Testing of APIs

8) SOP Version

Version 1.0