StabilityStudies.in

SOP for Conducting Stability Studies for Low-Dose Formulations

Standard Operating Procedure for Stability Testing of Low-Dose Drug Formulations

1) Purpose

The purpose of this SOP is to establish a procedure for conducting stability studies on low-dose formulations, ensuring that the drug maintains its potency, purity, and safety throughout its shelf life.

2) Scope

This SOP applies to all low-dose formulations 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 assay and impurity profiling.
Quality Assurance (QA) Team: Reviews and approves the stability study protocol and

final reports.

Production Team: Provides samples and ensures documentation of production records.

4) Procedure

Sample Collection and Preparation
1. Collect representative samples of low-dose drug formulations from production batches.
2. Store samples under the recommended conditions until stability testing begins.
Development of Stability Study Protocol
1. Draft
  “Unlock the Secrets to Long-lasting Medicine: Ensuring the Stability of Drugs and Dosage Forms for Optimum Effectiveness!”
  a protocol detailing storage conditions, test intervals, and analytical methods (e.g., HPLC for assay and impurities).
2. Submit the protocol for approval to 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).
2. Perform analytical tests at each interval to assess potency, purity, and degradation products.
3. Document all results, observations, and any deviations from the protocol.
Data Analysis and Reporting
1. Analyze stability data to confirm that the low-dose formulation maintains its specifications over time.
2. Prepare a comprehensive stability report and submit it 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: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products

8) SOP Version

Version 1.0