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