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SOP for Conducting Stability Studies for Hormone Replacement Therapies

Standard Operating Procedure for Stability Testing of Hormone Replacement Therapies

1) Purpose

The purpose of this SOP is to establish a procedure for conducting stability studies on hormone replacement therapies (HRTs) to ensure they maintain their potency, safety, and efficacy throughout their shelf life.

2) Scope

This SOP applies to all hormone replacement therapy products 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 potency assays, impurity profiling, and dissolution tests.
Quality Assurance (QA) Team: Ensures

protocol compliance and reviews final reports.

Production Team: Provides necessary samples and maintains proper documentation of production batches.

4) Procedure

Sample Collection and Preparation
1. Collect representative samples from each batch of hormone replacement therapy products.
2. Store samples under appropriate conditions until the stability
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Development of Stability Study Protocol
1. Draft a protocol detailing the storage conditions, test intervals, and analytical methods (e.g., HPLC for potency and impurities).
2. Submit the protocol for approval by the QA and Regulatory Affairs teams.
Conducting the Stability Study
1. Store samples in stability chambers under defined conditions (e.g., 25°C/60% RH, 30°C/75% RH).
2. Perform stability tests at each specified interval to assess potency, impurity levels, and dissolution profiles.
3. Document all observations, test results, and any deviations from the protocol.
Data Analysis and Reporting
1. Analyze the stability data to determine any changes in the drug’s potency, impurity levels, or dissolution profiles over time.
2. Prepare and submit a comprehensive stability study report to the QA team for review and approval.

5) Abbreviations, if any

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

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
FDA Guidance for Industry: Estrogen and Estrogen/Progestin Drug Products for Hormone Replacement Therapy

8) SOP Version

Version 1.0