Troubleshooting Tips & Best Practices for Environmental 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.
Download the NEW Validation eBook and you will learn:
• Sensor placement: where, how many, and for how long?
• Validation Master Plan checklist
• Links to 1-hour webinars: Protocols, GAMP Guidance, and Regulations on Validation
Download eBook now