Protocol for Assessing Stability of Investigational Compounds in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the stability testing of study compounds in Bioavailability (BA) and Bioequivalence (BE) studies, ensuring the integrity, potency, and safety of investigational products throughout the study duration.

Scope

This SOP applies to all study personnel involved in the handling, storage, and testing of investigational compounds used in BA/BE studies, including Investigators, Pharmacists, and Quality Assurance Personnel.

Responsibilities

• The Investigator is responsible for overseeing the stability testing of investigational compounds at study sites, ensuring compliance with study protocols, regulatory requirements, and quality standards.
• The Pharmacist is responsible for managing the storage and dispensing of investigational compounds, maintaining appropriate storage conditions, and coordinating stability testing activities with laboratory personnel.
• The Quality Assurance Personnel is responsible for monitoring stability testing procedures, reviewing and approving stability testing protocols, and ensuring compliance with regulatory requirements and quality standards.

Procedure

1. Develop stability testing protocols outlining the objectives, testing conditions, sampling schedules, and acceptance criteria for assessing the stability of investigational compounds under different storage conditions.
2. Establish storage conditions for investigational compounds based on stability testing requirements and regulatory guidelines, including temperature, humidity, light exposure, and container closure systems.
3. Conduct stability testing of investigational compounds according to predefined protocols, using validated analytical methods to assess the chemical, physical, and microbiological stability of the compounds over time.
4. Collect stability samples at designated time points throughout the study duration, following appropriate sampling procedures and labeling requirements to ensure traceability and integrity of samples.
5. Analyze stability samples using validated analytical methods, such as chromatography, spectrophotometry, or microbiological assays, to determine the concentration, purity, and potency of investigational compounds at each time point.
6. Evaluate stability data to assess the degradation kinetics, degradation pathways, and shelf-life of investigational compounds under different storage conditions, comparing results against predefined acceptance criteria and regulatory guidelines.
7. Document all stability testing activities, including testing protocols, sampling schedules, analytical results, and stability reports, in a stability testing log or database for review and approval by Quality Assurance Personnel.
8. Implement corrective actions and process improvements based on stability testing findings, addressing any stability issues or deviations identified during testing, to ensure the integrity and safety of investigational compounds throughout the study duration.

Abbreviations

• SOP – Standard Operating Procedure
• BA – Bioavailability
• BE – Bioequivalence

Documents

• Stability Testing Protocol
• Stability Testing Log or Database
• Stability Reports
• Corrective Action Reports

Reference

International Council for Harmonisation (ICH) Q1A (R2) Stability Testing of New Drug Substances and Products guidelines and relevant regulatory guidelines for stability testing of investigational compounds in clinical research.

SOP Version

Version 1.0