StabilityStudies.in

SOP for Assessing Stability for Enzyme-Based Drugs

Standard Operating Procedure for Stability Testing of Enzyme-Based Therapeutics

1) Purpose

The purpose of this SOP is to establish a standardized procedure for assessing the stability of enzyme-based drugs to ensure they maintain their biological activity, potency, and safety throughout their shelf life.

2) Scope

This SOP applies to all enzyme-based drugs manufactured, tested, or stored within the facility. It is relevant to departments involved in production, quality control, quality assurance, and regulatory compliance.

3) Responsibilities

Quality Control (QC) Team: Conducts stability testing, including enzymatic activity assays, potency, and physical characterization.
Quality Assurance (QA) Team: Reviews and approves the stability study

protocols and final reports.

Production Team: Provides necessary samples and maintains accurate documentation.

4) Procedure

Sample Preparation
1. Collect representative samples of enzyme-based drugs from production batches.
2. Store samples under recommended conditions until stability testing begins.
Development of Stability Study Protocol
1. Draft a protocol detailing
  “Mastering Drug Stability: Unveiling the Revised Principles and Practices to Ensure Effective Medication Longevity”
  storage conditions, testing intervals, and analytical methods (e.g., enzymatic activity assays, HPLC).
2. Submit the protocol for review and approval to the QA and Regulatory Affairs teams.
Conducting the Stability Study
1. Store samples in stability chambers under specified conditions (e.g., 2-8°C, -20°C).
2. Perform tests at each interval to assess enzymatic activity, potency, and other relevant stability parameters.
3. Document all test results, observations, and any deviations from the protocol.
Data Analysis and Reporting
1. Analyze stability data to determine whether the enzyme-based drug meets predefined acceptance criteria over time.
2. Prepare a comprehensive stability study report and submit it to the QA team for review and approval.

5) Abbreviations, if any

QC: Quality Control
QA: Quality Assurance
HPLC: High-Performance Liquid Chromatography

6) Documents, if any

Stability Study Protocol
Analytical Test Reports
Stability Study Report

7) Reference, if any

ICH Q5C: Stability Testing of Biotechnological/Biological Products
FDA Guidance for Industry: Enzyme Replacement Therapy

8) SOP Version

Version 1.0