SOP for Assessing the Impact of Humidity on Drug Stability

Standard Operating Procedure for Humidity Impact Assessment on Drug Stability

1) Purpose

The purpose of this SOP is to outline the procedure for assessing the impact of humidity on drug stability. This study aims to ensure that drug products retain their quality and efficacy when exposed to varying humidity conditions.

2) Scope

This SOP applies to all drug products that may be sensitive to humidity, including tablets, capsules, and powders, 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 under different humidity conditions using validated analytical methods.

Quality Assurance (QA) Team: Reviews and approves the protocol and final reports, ensuring compliance with guidelines.

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

4) Procedure

Sample Preparation
1. Collect representative samples from
  “Unveiling the Viability of Veterinary Drugs: In-depth Analysis and Crucial Stability Studies for Animal Health Excellence!”
  production batches that are known to be sensitive to humidity.
2. Store samples under controlled conditions until stability testing begins.
Development of Stability Study Protocol
1. Draft a protocol detailing storage conditions (e.g., 25°C/60% RH, 40°C/75% RH), test intervals, and analytical methods (e.g., moisture content, dissolution testing).
2. Submit the protocol for approval to the QA and Regulatory Affairs teams.
Conducting the Stability Study
1. Store samples in stability chambers with controlled humidity levels as per the protocol.
2. Perform tests at each interval to evaluate the drug’s stability, including physical appearance, dissolution rate, and potency.
3. Document all observations, test results, and any deviations from the protocol.
Data Analysis and Reporting
1. Analyze stability data to determine the impact of humidity on the drug’s quality, safety, and efficacy over time.
2. Prepare a detailed stability study 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: Stability Testing of Drug Substances and Drug Products

8) SOP Version

Version 1.0