StabilityStudies.in

SOP for Evaluating Stability for Drugs in Novel Packaging

Standard Operating Procedure for Stability Testing of Drugs in Innovative Packaging

1) Purpose

The purpose of this SOP is to establish a standardized approach for evaluating the stability of drugs stored in novel or innovative packaging materials to ensure the packaging does not adversely affect the drug’s safety, potency, or quality throughout its shelf life.

2) Scope

This SOP applies to all drug products stored in new or innovative packaging materials, such as biodegradable, smart, or child-resistant packaging, 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 physical, chemical, and functional assessments of the packaging and the drug product.
Quality Assurance (QA) Team: Reviews and approves the stability study protocols and reports.
Production Team: Provides necessary
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samples and maintains production records related to the novel packaging.

4) Procedure

Sample Preparation
1. Collect representative samples of drug products in the novel packaging from production batches.
2. Store samples under controlled conditions until the stability study begins.
Development of Stability Study Protocol
1. Prepare a protocol detailing storage conditions, testing intervals, and analytical methods (e.g., integrity testing, extractable/leachable testing).
2. Submit the protocol for review and approval to the QA and Regulatory Affairs teams.
Conducting the Stability Study
1. Store samples in stability chambers under specified conditions (e.g., 25°C/60% RH, 30°C/75% RH).
2. Perform tests at each interval to evaluate the stability of the drug product in the novel packaging.
3. Document all test results, observations, and any deviations from the protocol.
Data Analysis and Reporting
1. Analyze the data to determine if the novel packaging maintains the stability of the drug product over time.
2. Prepare a comprehensive report and submit it to the QA team for review and approval.

5) Abbreviations, if any

QC: Quality Control
QA: Quality Assurance
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: Container Closure Systems for Packaging Human Drugs and Biologics

8) SOP Version

Version 1.0