On-demand webinar
A practical guide for winter temperature mapping in GxP
(+ what is changing in GxP)
Timely winter mapping is a requirement for many controlled environments in GMP and GDP. Is it for yours? Watch how to determine if seasonal mapping is needed for your facility and how to conduct (winter) mapping aligned with WHO, ISPE, and FDA guidelines.
Are you ready for your winter mappings?
Winter mapping is one of those requirements that sounds simple – until you start planning it.
- When exactly does the winter window start?
- How long should the study run?
- Does your facility even need one?
The answers depend on your environment, products, and regulatory framework.
Is it needed?
When is seasonal temperature mapping required – and when is it not?
How to do it?
What are the best practices for conducting seasonal temperature mapping in GxP?
What's in the guidelines?
What do the WHO, FDA, GxP, and other standards say about winter mapping?
Key takeaways
- How to determine whether seasonal mapping is a requirement for your facility
- Guidelines for seasonal mapping aligned with WHO, ISPE, and FDA
- How to prevent seasonal mapping from delaying new facility qualification
- The common pitfalls when conducting a mapping during wimter
- What has changed in GxP – and what it means for seasonal qualification