Guidelines for Stability Testing of Hormonal Products
1) Purpose
The purpose of this SOP is to outline the procedures for conducting stability studies on hormonal products. Hormonal products are susceptible to degradation due to environmental factors like temperature, light, and humidity. This SOP aims to determine their stability and establish appropriate storage conditions to ensure their safety and efficacy.
2) Scope
This SOP applies to all hormonal products, including tablets, capsules, injectables, and transdermal patches, handled or stored by the organization. It is intended for personnel involved in formulation, quality control, and regulatory compliance.
3) Responsibilities
Formulation Scientist: Responsible
Quality Control (QC) Team: Responsible for conducting the required tests and recording data.
QA Team: Responsible for reviewing and approving the stability study protocol and final report.
4) Procedure
4.1 Study Design:
- Identify stability-indicating parameters (e.g., potency, purity, dissolution rate, and content uniformity) relevant to the hormonal product.
- Define the storage conditions (e.g., room temperature, refrigeration, and controlled humidity) to be tested based on product characteristics and regulatory requirements.
- Develop a study protocol that includes sampling schedules, analytical methods, and acceptance criteria.
4.2 Sample Preparation:
- Prepare samples from representative batches according to standard manufacturing procedures.
- Label samples appropriately with batch numbers, storage conditions, and sampling time points.
- Store samples in designated stability chambers under specified conditions.
4.3 Testing Schedule:
- Perform initial testing to establish baseline data for all parameters.
- Conduct stability tests at predetermined intervals to assess changes over time.
- Record all test results and analyze data for trends or deviations.
4.4 Data Analysis and Reporting:
- Analyze data using statistical methods to determine the stability of the hormonal product over time.
- Prepare a report summarizing the study’s findings, conclusions, and recommendations for storage conditions.
- Submit the report for QA review and archiving.
5) Abbreviations, if any
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
Hormonal Product Stability Protocol: Document detailing the study plan.
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