SOP for Conducting Stability Studies for Combination Products as per Regulatory Guidelines

Guidelines for Stability Studies of Combination Products

1) Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the process for designing stability studies for combination products in accordance with relevant regulatory guidelines. This SOP ensures that stability studies provide adequate data to support the quality, safety, and efficacy of combination products.

2) Scope

This SOP applies to all personnel involved in the design, execution, and documentation of stability studies for combination products intended for global markets.

3) Responsibilities

Stability Testing Team: Responsible for designing and conducting stability studies for combination products, and

ensuring proper documentation.

Quality Assurance (QA) Team: Responsible for reviewing and approving stability study protocols and reports, ensuring compliance with regulatory requirements.

Regulatory Affairs Team: Responsible for ensuring that the study design meets the expectations of the relevant regulatory authorities.

4) Procedure

4.1 Study Design Preparation

4.1.1 Identify the

components of the combination product (e.g., drug-device, drug-drug) and the regulatory requirements applicable to each component.

4.1.2 Determine the types of stability studies required (e.g., long-term, accelerated, forced degradation) based on the product’s intended use and market.

4.1.3 Develop a stability protocol that includes study design, testing schedule, storage conditions, and testing parameters as per regulatory guidelines.

4.2 Selection of Batches and Samples

4.2.1 Select representative batches of the combination product for the study, considering the range of configurations and production variations.

4.2.2 Ensure sufficient samples are prepared to cover the entire study duration, considering the number of time points and tests to be conducted.

4.3 Conducting the Stability Studies

4.3.1 Store samples under the defined conditions, monitoring temperature, humidity, and other relevant environmental factors.

4.3.2 At each specified time point, conduct stability-indicating tests on all components of the combination product to assess physical, chemical, and functional stability.

4.3.3 Record all results meticulously in stability data sheets, ensuring accuracy and traceability of data.

4.4 Data Analysis and Reporting

4.4.1 Review the stability data to identify any trends, deviations, or out-of-specification (OOS) results.

4.4.2 Compile a stability report that includes the study design, results, conclusions, and any necessary recommendations for shelf life and storage conditions.

5) Abbreviations, if any

QA: Quality Assurance
OOS: Out-of-Specification

6) Documents, if any

Stability protocol, stability data sheets, stability testing records, stability report.

7) Reference, if any

Relevant regulatory guidelines for combination products, ICH Guidelines.

8) SOP Version

Version 1.0