Glossary
Intermediate Testing
What is Intermediate Testing?
Intermediate testing refers to a procedure used to ensure that a craft’s engine or system meets specific standards and requirements during various stages of its operation, particularly after installation or modifications. This type of testing is conducted by a competent authority to verify that the system functions correctly and safely before it is put into full operation. The goal of intermediate testing is to identify any issues that may arise during the operation of the system, ensuring compliance with safety and performance standards.
What are the benefits of Intermediate testing in pharma?
The benefits of intermediate testing in the pharmaceutical industry include:
- Stability Assessment: Intermediate testing evaluates a drug product’s stability under specific conditions, helping to determine how it performs over time. This is crucial for establishing shelf life and storage requirements.
- Regulatory Compliance: Conducting intermediate testing aligns with regulatory guidelines, such as those from the International Council for Harmonization (ICH), ensuring that pharmaceutical products meet necessary safety and efficacy standards.
- Quality Assurance: By identifying potential degradation pathways and changes in a product’s physical, chemical, and microbiological properties, intermediate testing helps maintain high-quality standards throughout the product’s lifecycle.
- Risk Management: Intermediate testing aids in identifying risks associated with product degradation under various environmental conditions, allowing manufacturers to implement strategies to mitigate these risks.
