Tips And Best Practices For Troubleshooting Biopharma Temperature Validation/Mapping
The FDA mandates the validation of environmental conditions that can affect the strength, identity, safety, quality, and purity of pharmaceuticals, medical devices, or biologics. To meet these requirements for temperature or humidity, we perform a mapping validation, usually as part of an installation qualification and operational qualification of the environment, be it: incubator, fridge/freezer, stability chamber, cold room, or warehouse.
This document discusses the following topics:
- 5 Frequently asked questions about temperature and humidity validation/mapping
- 5 scientifically sound steps to determining how to monitor temperature in your GXP space
- Mapping Validation sensor placement: the whole warehouse and nothing but the warehouse
- Sensor placement troubleshooting – sensor response times & mapping in-air or in-media
- The validation Master Plan
- How to Validate your CMS software according to GAMP
Source: Vaisala
