- Pharmaceutical Consultancy
- Mapping and Transport Validation
- Transport Validation
Transport Validation
It is essential to maintain the temperature of products throughout the transportation environment. It is an area where product can be exposed to extreme conditions, exceeding temperatures that they were exposed to during stability. The question then arises – Is the product suitable for release to the market?
Transport validation is essential to ensure their suitable for of use and appropriately equipped to prevent exposure of the products to conditions that could affect their quality and packaging integrity.
FQS offers a tailored services to each client, taken into consideration the products, transport conditions, internal policies, and all applicable referenced regulations. Services can include installation qualification (IQ), operational qualification (OQ) and/or route qualification of ambient or cold chain vehicles depending on the specific client requirements.
Transport Validation Project Includes:
- Audit and approval of transport companies
- Qualification of reefers, qualification of routes, including risk assessments (matrix approach where possible).
- Compilation of policies, protocols, risk assessments.
- Execute Mapping Where Required Complete Risk Assessment On Excursions
- Review Stability Policies to Ensure They Cover Possible Transport Exposures
- Supply of report with data in summary, graphical and table format