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SOP for Performing Stability Studies for Drugs with Special Storage Requirements

Standard Operating Procedure for Stability Testing of Drugs Requiring Special Storage Conditions

1) Purpose

The purpose of this SOP is to provide a standardized procedure for conducting stability studies on drugs that require special storage conditions. These studies are essential to ensure that the drugs maintain their quality, safety, and efficacy throughout their shelf life under specified storage requirements.

2) Scope

This SOP applies to all drugs that require special storage conditions, such as refrigeration, protection from light, or specific humidity levels. It is relevant to departments involved in manufacturing, quality control, quality assurance,

and regulatory compliance of such drug products.

3) Responsibilities

Quality Control (QC) Team: Conducts stability testing and documents results.
Quality Assurance (QA) Team: Reviews test results and ensures compliance with regulatory requirements.
Production Team: Supplies the necessary samples and maintains records of batch
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production.

4) Procedure

Identification of Storage Requirements
1. Determine the specific storage conditions required for the drug product (e.g., 2-8°C, protect from light, etc.).
2. Prepare stability samples according to these specific conditions.
Development of Stability Study Protocol
1. Draft a stability study protocol that outlines the testing intervals, conditions, and sample sizes required for the study.
2. Obtain approval for the protocol from the QA and Regulatory Affairs teams.
Execution of Stability Study
1. Place the samples under the specified storage conditions as per the protocol.
2. Conduct analytical tests at each specified interval to evaluate physical, chemical, and microbiological stability.
3. Document all results and any deviations from the protocol.
Data Analysis and Reporting
1. Analyze the stability data to identify trends and determine if the product remains stable under special storage conditions.
2. Prepare a detailed report and submit it to the QA team for review.

5) Abbreviations, if any

QC: Quality Control
QA: Quality Assurance

6) Documents, if any

Stability Study Protocol
Analytical Test Reports
Stability Study Report

7) Reference, if any

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

8) SOP Version

Version 1.0