How do temperature requirements affect the compliance of your organization?

   Selected FDA inspections guides are referenced below.

 

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
Bulk Pharmaceutical Chemicals	6
DRUGS
Lyophilization of Parenterals	39
Microbiological. Pharmaceutical Quality Control 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
Cosmetic Product Manufacturers	2
Computerized Systems in the 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
OTHER COMPUTERS
Computerized Systems in Drug Establishments
Glossary Comp. Systems. Software Development Terminology
DEVICES
Quality Systems
Electromagnetic Compatibility Aspects of Medical Device Quality Systems
Bioresearch Monitoring Inspections of In- vitro Diagnostic Devices
Medical Device Manufacturers