How do temperature requirements affect the regulatory compliance of your organization?

Selected U.S. Food and Drug Administration inspection guides and the number of references to the word "temperature":

FDA Inspection Guide	Number of temperature requirements/references
BIOTECHNOLOGY
Biotechnology Inspection Guide	13
Blood Banks	24
Infectious Disease Marker Testing Facilities	10
Viral Clearance Process for Plasma Derivatives	4
DRUGS
Bulk Pharmaceutical Chemicals	6
High Purity Water Systems	2
Lyophilization of Parenterals	39
Microbiological. Pharmaceutical QC Labs	2
Dosage Form Drug Manufacturers - CGMP'S	9
Oral Solid Dosage Forms Pre/post Appr. Issues	3
Sterile Drug Substance Manufacturers	6
Topical Drug Products	15
Oral Solutions and Suspensions	7
FOOD
Aseptic Processing and Packaging	52
Computerized Systems Food Processing Industry	45
Guide to Produce Farm Investigations	6
Interstate Carriers and Support Facilities	23
Dairy Product Manufacturers	50
Miscellaneous Food Products-Vol. 1	17
Miscellaneous Food Products-Vol. 2	9