The U.S. Food and Drug Administration’s (FDA) regulations tell us that we must identify the environmental conditions that can affect the strength, identity, safety, quality, and purity of our regulated products, whether they are pharmaceuticals, medical devices, or biologic products.

The FDA regulations also say we must be able to demonstrate that we have maintained our product storage spaces such that the required storage conditions for our products have been met.

To meet these requirements for temperature or humidity, the common industry practice is to perform a mapping validation, usually in conjunction with an installation qualification and operational qualification of the equipment involved (e.g., incubator, refrigerator, freezer, stability chamber, cold room, or warehouse).

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