Glossary

Stability Protocol Report

What is Stability Protocol Report?

Stability Protocol Report is a document that outlines the stability testing plan and results for a pharmaceutical product. It is a critical component in ensuring the quality, safety, and efficacy of drugs throughout their shelf life.

What are the key elements of Stability Protocol Report?

  • Precise formulation and container specifications
  • Intended storage conditions and shelf-life
  • Acceptance criteria for each test parameter
  • Validated test methods
  • Sampling time points and storage conditions

What is the role of Stability Protocol Report in ensuring the quality of pharma products?

  • Stability Protocol Report outlines the stability study design, including the number of batches, containers, storage conditions, and test parameters to be evaluated
  • Provides the data and evaluation to support the proposed shelf-life and recommended storage conditions for the drug product
  • Aligns with ICH and other relevant guidelines for stability testing requirements
  • Provides the stability data and analysis to support informed decisions about the product’s quality, packaging, and storage
  • Serves as a comprehensive record of the stability testing procedures and results