Guidelines for Stability Testing of Drug Products Under Extreme Conditions

1) Purpose

The purpose of this SOP is to provide a standardized procedure for conducting stability studies on drug products under extreme conditions. Stability testing ensures that drug products maintain their safety, efficacy, and quality when exposed to extreme temperatures, humidity, and light conditions.

2) Scope

This SOP applies to all drug products, including solid, liquid, and semi-solid formulations, produced or handled by the organization. It is intended for personnel involved in formulation development, quality control, and regulatory compliance.

3) Responsibilities

Formulation Scientist: Responsible for designing the stability study protocol and selecting appropriate extreme conditions and stability-indicating parameters.

Quality Control (QC) Team: Responsible for conducting stability tests according to the approved protocol and documenting results.

QA Team: Responsible for reviewing data, ensuring regulatory compliance, and approving the final stability report.

4) Procedure

4.1 Study Design:

1. Identify stability-indicating parameters (e.g., degradation, potency, moisture
   

   Formulation Characterization and Stability of Protein Drugs

   content, physical changes) relevant to the drug product.
2. Select appropriate analytical methods (e.g., HPLC, UV Spectroscopy, Karl Fischer Titration) to evaluate these parameters.
3. Define extreme conditions (e.g., 40°C/75% RH, freeze-thaw cycles, direct sunlight exposure) based on the product’s characteristics and regulatory guidelines.
4. Develop a study protocol outlining the objectives, sampling schedule, and analytical methods to be used under extreme conditions.

4.2 Sample Preparation:

1. Prepare samples from representative production batches and label them with batch numbers, storage conditions, and sampling time points.
2. Store samples in designated stability chambers with controlled extreme conditions as specified in the study protocol.

4.3 Testing Schedule:

1. Conduct initial testing on all samples to establish baseline data for the selected parameters.
2. Perform follow-up testing at predetermined intervals (e.g., 1 month, 3 months, 6 months) to monitor changes under extreme conditions.
3. Document all test results and analyze data for trends or deviations from acceptance criteria.

4.4 Data Analysis and Reporting:

1. Analyze data using statistical methods to determine trends and compliance with acceptance criteria.
2. Prepare a stability study report summarizing findings, conclusions, and recommendations for storage and handling under extreme conditions.
3. Submit the report for QA review and archiving.

5) Abbreviations, if any

QC: Quality Control

QA: Quality Assurance

HPLC: High-Performance Liquid Chromatography

6) Documents, if any

Extreme Condition Stability Protocol: Document detailing the study plan and methodology.

Analytical Data Records: Data sheets for all tests performed.

7) Reference, if any

ICH Q1A(R2): Stability Testing of New Drug Substances and Products

8) SOP Version

Version 1.0