Standard Operating Procedure for Assay of Active Ingredient in Powders

1) Purpose

The purpose of this SOP is to outline the procedure for conducting assay testing of the active pharmaceutical ingredient (API) in powder formulations to ensure the potency and quality of the product.

2) Scope

This SOP applies to all personnel involved in the assay testing of active ingredients in powder formulations within the pharmaceutical quality control (QC) department.

3) Responsibilities

Analytical Chemist: Responsible for performing assay testing and documenting results.
Quality Assurance (QA) Department: Responsible for reviewing and approving the assay testing procedure and results.

4) Procedure

1. Sample Preparation:
   1. Prepare the sample following specified procedures, ensuring accurate measurement and representation of the batch.
   2. Handle and store samples according to appropriate conditions to maintain stability and integrity.
2. Testing Method:
   1. Utilize validated analytical methods such as high-performance liquid chromatography (HPLC) or spectrophotometry for assay determination.
   2. Calibrate equipment and ensure suitability for the intended use.
3. Analysis:
   1. Perform assay testing according to established protocols and specifications.
   2. Record observations and any deviations encountered during testing.
4. Data Analysis and Interpretation:
   1. Analyze test results and calculate the concentration of the active ingredient based on calibration standards.
   2. Evaluate results against acceptance criteria to determine compliance with specifications.
5. Reporting:
   1. Prepare an assay testing report summarizing the procedure, results, calculations, and conclusions.
   2. Submit the report to the QA department for review and approval.
6. Documentation:
   1. Maintain accurate records of all assay testing activities, including raw data, calculations, and reports.
   2. File documentation in accordance with Good Documentation Practices (GDP).

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
API: Active Pharmaceutical Ingredient
HPLC: High-Performance Liquid Chromatography
GDP: Good Documentation Practices

6) Documents, if any

Assay Testing Protocol, Test Results, Assay Testing Report

7) Reference, if any

Pharmacopeial guidelines for assay testing of pharmaceutical ingredients.

8) SOP Version

Version 1.0