References to the Word "Temperature" in the FDA's Internal Inspection Training Guides

The following table shows the number of references to the word "temperature" in some of the inspection guides that are used by the US Food and Drug Administration to train their auditors.

A search of the word "temperature" in the FDA warning letter database returns more than 1600 items.

 

FDA Inspection Guide

#  of References to the Word "Temperature"

   

BIOTECHNOLOGY

 
Biotechnology Inspection Guide

13

Infectious Disease Marker Testing Facilities

10

Viral Clearance Process for Plasma Derivatives

4

   

DRUGS

 
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 Solid Dosage

7

   

FOOD

 
Aseptic Processing and Packaging

52

Computerized Systems Food Processing Industry

45

Guide to Produce Farm Investigations

6

Dairy Product Manufacturers

50

Miscellaneous Food Products-Vol. 1

17

Miscellaneous Food Products-Vol. 2

9

   

 

877 FRZ TEMP ( 877 379 8367)

877 GLP TEMP ( 877 457 8367)

The Tempurity™ System will collect data from ALL of your organizations monitored devices, wherever they are in the world. For different perspectives you may wish to read more from specific categories below: