12/22/2010 Inspection Technical Guides

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Inspection Technical Guides
DEPT OF HEALTH AND HUMAN SERVICES
Date: 11/30/87
Number: None

PUBLIC HEALTH SERVICE

FOOD AND DRUG ADMINISTRATION

Related Program Areas:

ORO/ETSB (HFC-133) All Programs

SUBJECT: TABLE OF CONTENTS

This issuance has been written to serve as a Table of Contents for preceeding ITG issues. New
ITG's should be added as they are received. The Table of Contents will be revised and
redistributed as necessary.

INSPECTION TECHNICAL GUIDES

CONTENTS

This issuance has been written to serve as a Table of Contents for preceeding ITG issues. New
ITG's should be added as they are received. The Table of Contents will be revised and
redistributed as necessary.

No. Subject Related Program Areas Date

Issued
1. Introductory Issue 1 All Programs 1/20/72
2. Steam Generation in Canneries 2 Food Canneries 2/11/72
3. Steam Distribution for Retort3 Food Canneries 3/03/72
Venting in Food Canneries
4. New Equipment Kenics 4 Food, Drug and Cosmetic 3/20/72
Static Mixers
5. Ethylene Oxide 5 Drugs, Sterile Devices 6/09/72
Sterilization 1.
Calculation of Initial
Gas Concentration
6. Leak Testing Sealed Ampuls 6 Drugs, Human and Veterinary 4/28/72
of Parenteral Solutions Injectable Vitamins
7. Sterilizing Symbols 7 Low Acid Canned Foods 1/09/72
(D, Z, F)
8. "Package Unit" Italian 8 Flour Mills Cereal Flours & Related 12/14/72
Products
9. Polariscope 9 Sterile Packaging - Foods, 5/21/73
Drugs, Devices, Hardened
Lenses
10. Diathermy10 Medical Devices 5/21/73
11. Steam Pressure for11 Sterile Drugs and Devices Low 6/29/73
Retorts and Autoclaves Acid Canned Foods, Biologics
12. Stroboscope 12 Food, Drug, Device, Manufacture 8/08/73
and Packaging
13. Field Submission of13 All Programs 9/05/73
Articles (8/03/84
Revised)
14. Thermocouple Surface 14 Food Canneries 12/20/73
Pyrometers
15. Common Valves Used in15 Sterile Drugs,Devices, Low Acid 1/15/74
Process Fluid Systems Canned Foods and Biologics
16. A.T.I. Steam Activated 16 Food, Drugs, Medical Devices 3/08/74
Heat Sensitive Indicators

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17. New Source of Lead and 17 Various Foods and Drugs 6/18/74
Other Contamination
18. Ultrasound in the Food,18 Food, Drugs, and Medical 3/03/75
Drug, and Device Industries Devices
19. Screening Electronic19 Medical Devices 4/20/75
Components
20. Hermetically Sealed 20 Medical Devices 7/18/75
Electronic Component
Leak Detection
21. Noise Control Mufflers 21 Food, Drugs 9/15/75
for Bleeders on Retorts and Sterilizers
22. Ground Fault Circuit22 All Programs, Personnel Safety 3/05/76
Interrupter
23. The Computer in FDA23 Foods, Drugs, and Medical 5/21/76
Regulated Industries Devices
24. Air Velocity Meters 24 Sterile Drugs andDevices, Foods 7/30/76
and Cosmetics
25. Ethylene Oxide 25 Sterile Devices, Drugs 9/01/76
Sterilization 2. Graphical Aid to Determine Gas
Concentration
26. Evaluation of Production 26 Cleaning Processes for Medical Devices 1/07/77
Electronic Medical Devices - Part 1, Contaminants
27. Evaluation of Production 27 Medical Devices 1/07/77
Cleaning Processes for Electronic Medical Devices -
Part II, Cleaning Solvents
28. Evaluation of Production 28 Medical Devices 1/07/77
Cleaning Processes for Electronic Medical Devices -
Part III, Methods
29. The Computer in FDA29 All Programs 9/22/77
Regulated Industries - Part II Computer Hardware
30. The Nation is Going Metric30 All Programs 12/02/77
(rescinded)
31. Electronic Components -31 Medical Devices, Radiological 1/16/78
Resistors Health
32. Pyrogens, Still a Danger32 Parenterals, Biologicals, 1/12/79
Devices, Drugs
33. Use of the Texas Instruments 33 X-Ray Field Testing 7/12/79
Model 59 Programmable Calculator in the
Enforcement of the Diagnostic X-ray Performance
Standard
34. Heat Exchangers to Avoid 34 Drugs, Diagnostic Products 7/31/79
Contamination Biologics
35. Reliability of Manufactured 35 Medical Device, Radiological 9/26/80
Products Health Products
36. Reverse Osmosis 36 Drugs, Medical Devices and 10/21/80
Diagnostic Products
37. Temperature Sensors in37 Foods, Drugs, Biologics, Medical 1/7/83
the Regulated Industry Devices and Diagnostic Products
38. Industrial Applications of38 All Programs 8/1/83
New Biochemical Technolgy
39. Water Activity (a{{w}}) in Foods 39 Foods 4/16/84
40. Bacterial Endotoxins/Pyrogens 40 Drugs and Devices 3/20/85
41. Expiration Dating and 41 Drugs 10/18/85
Stability Testing for Human Drug Products
42. Tin W hiskers - Problems,42 Medical Devices 3/14/86
Causes, and Solutions
43. Lyophilization of Parenterals 43 Drugs, Biologics, Diagnostics 4/18/86
44. Radiation Protection Terminology44 Foods 5/15/86
45. Circular Temperature Recording 45 All Programs 2/20/87
Chart Measurements
46. Water for Pharmaceutical Use 46 Drugs, Biologics, Medical Devices 12/31/86
47. Measurement of Relative Humidity47 Drugs and Medical Devices 4/30/87
in the ETO Process
48. Microbiological Contamination 48 All Programs 12/31/86
of Equipment Gaskets w ith Product Contact
49. Stock Rotomat49 Foods 5/30/87
50. Capacitor50 Medical Devices/Radiological 10/23/87
Health
51. Electronic Relays 51 Medical Devices/Radiological 11/10/87
Health
52. Voice Recognition Systems 52 GLP and Devices 11/10/87

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move and destroy table of contents date 4/30/87.

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