SOP for Evaluating Stability for Drugs in Clinical Trials

Guidelines for Stability Testing of Drugs in Clinical Trials

1) Purpose

The purpose of this SOP is to establish procedures for evaluating the stability of drugs used in clinical trials. Stability studies ensure that investigational drugs maintain their safety, potency, and efficacy throughout the trial period under various storage and handling conditions.

2) Scope

This SOP applies to all drugs used in clinical trials conducted or sponsored by the organization. It covers all phases of clinical trials, from Phase I to Phase III, and includes oral, injectable, and other dosage forms.

3) Responsibilities

Clinical Trial Manager: Responsible for

coordinating stability studies with the formulation and quality control teams.

Quality Control (QC) Team: Responsible for conducting stability tests and recording results.

Regulatory Affairs Team: Responsible for ensuring compliance with regulatory guidelines related to clinical trials.

4) Procedure

4.1 Study Design:

Define the stability parameters to be tested, such
“Unlock the Secrets of Drug Stability: Essential Guide for Pharmaceutical Scientists to Ensure Safe and Effective Medications”
as potency, purity, dissolution, and sterility.
Select appropriate storage conditions (e.g., room temperature, refrigeration, and light exposure) based on the drug’s intended use.
Prepare a detailed stability study protocol, including sampling schedules and analytical methods.

4.2 Sample Preparation:

Prepare samples from representative clinical batches and label them appropriately.
Store samples in designated stability chambers according to the defined conditions.

4.3 Testing Schedule:

Conduct initial testing to establish baseline data for the selected parameters.
Perform follow-up testing at predetermined intervals to monitor changes over time.
Document all test results and analyze data for trends or deviations.

4.4 Data Analysis and Reporting:

Analyze data to determine if the drug meets predefined acceptance criteria for each time point.
Prepare a stability study report summarizing findings, conclusions, and recommendations for storage and handling.
Submit the report for QA review and archiving.

5) Abbreviations, if any

QC: Quality Control

6) Documents, if any

Clinical Trial Stability Protocol: Document outlining 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

ICH E6(R2): Good Clinical Practice

8) SOP Version

Version 1.0