Guidelines for Stability Testing of Low-Dose Formulations

1) Purpose

The purpose of this SOP is to provide a standardized procedure for conducting stability studies on low-dose formulations. Stability testing ensures that these formulations maintain their safety, efficacy, and quality throughout their shelf life under various storage conditions.

2) Scope

This SOP applies to all low-dose 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 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., potency, content uniformity, degradation) relevant to the low-dose formulation.
2. Select appropriate analytical methods (e.g., HPLC, UV Spectroscopy) to evaluate these parameters.
3. Define storage
   

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   conditions (e.g., room temperature, refrigerated) 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.

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 under specified conditions.

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 in stability over time.
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 conditions.
3. Submit the report for QA review and archiving.

5) Abbreviations, if any

QC: Quality Control

QA: Quality Assurance

6) Documents, if any

Low-Dose Formulation 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