inspection technical guides

Inspection Technical GuidesDEPT 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. NewITG's should be added as they are received. The Table of Contents will be revised andredistributed as necessary.

INSPECTION TECHNICAL GUIDES

CONTENTS

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

No. Subject Related Program Areas DateIssued

1. Introductory Issue1 All Programs 1/20/72

2.Steam Generation in Canneries2 Food Canneries 2/11/72

3.Steam Distribution for Retort3

Venting in Food Canneries

Food Canneries 3/03/72

4.New Equipment Kenics4

Static Mixers

Food, Drug and Cosmetic 3/20/72

5.Ethylene Oxide5

Sterilization 1.Calculation of InitialGas Concentration

Drugs, Sterile Devices 6/09/72

6.Leak Testing Sealed Ampuls6

of Parenteral Solutions

Drugs, Human and VeterinaryInjectable Vitamins

4/28/72

7.Sterilizing Symbols7

(D, Z, F)

Low Acid Canned Foods 1/09/72

8."Package Unit" Italian8 Flour Mills Cereal Flours & RelatedProducts

12/14/72

9.Polariscope9 Sterile Packaging - Foods,Drugs, Devices, HardenedLenses

5/21/73

10.Diathermy10 Medical Devices 5/21/73

11.Steam Pressure for11

Retorts and Autoclaves

Sterile Drugs and Devices LowAcid Canned Foods, Biologics

6/29/73

12.Stroboscope12 Food, Drug, Device, Manufactureand Packaging

8/08/73

13.Field Submission of13

Articles

All Programs 9/05/73(8/03/84Revised)

14.Thermocouple Surface 14

Pyrometers

Food Canneries 12/20/73

15.Common Valves Used in15

Process Fluid Systems

Sterile Drugs,Devices, Low AcidCanned Foods and Biologics

1/15/74

16.A.T.I. Steam Activated16

Heat Sensitive Indicators

Food, Drugs, Medical Devices 3/08/74

Inspections, Compliance, Enforcement, and Criminal Investigations

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17.New Source of Lead and17

Other Contamination

Various Foods and Drugs 6/18/74

18.Ultrasound in the Food,18

Drug, and Device Industries

Food, Drugs, and MedicalDevices

3/03/75

19.Screening Electronic19

Components

Medical Devices 4/20/75

20.Hermetically Sealed20

Electronic ComponentLeak Detection


21.Noise Control Mufflers21

for Bleeders on Retorts and Sterilizers

Food, Drugs 9/15/75

22.Ground Fault Circuit22

Interrupter

All Programs, Personnel Safety 3/05/76

23.The Computer in FDA23

Regulated Industries

Foods, Drugs, and MedicalDevices

5/21/76

24.Air Velocity Meters24 Sterile Drugs andDevices, Foodsand Cosmetics

7/30/76

25.Ethylene Oxide 25

Sterilization 2. Graphical Aid to Determine GasConcentration

Sterile Devices, Drugs 9/01/76

26.Evaluation of Production26Cleaning Processes forElectronic Medical Devices - Part 1, Contaminants


27.Evaluation of Production27

Cleaning Processes for Electronic Medical Devices -Part II, Cleaning Solvents


28.Evaluation of Production28

Cleaning Processes for Electronic Medical Devices -Part III, Methods


29.The Computer in FDA29

Regulated Industries - Part II Computer Hardware

All Programs 9/22/77

30.The Nation is Going Metric30

(rescinded)


31.Electronic Components -31

Resistors

Medical Devices, RadiologicalHealth

1/16/78

32.Pyrogens, Still a Danger32 Parenterals, Biologicals,Devices, Drugs

1/12/79

33.Use of the Texas Instruments33

Model 59 Programmable Calculator in theEnforcement of the Diagnostic X-ray PerformanceStandard

X-Ray Field Testing 7/12/79

34.Heat Exchangers to Avoid34

Contamination

Drugs, Diagnostic ProductsBiologics

7/31/79

35.Reliability of Manufactured35

Products

Medical Device, RadiologicalHealth Products

9/26/80

36.Reverse Osmosis36 Drugs, Medical Devices andDiagnostic Products

10/21/80

37.Temperature Sensors in37

the Regulated Industry

Foods, Drugs, Biologics, MedicalDevices and Diagnostic Products

1/7/83

38. Industrial Applications of38

New Biochemical Technolgy

All Programs 8/1/83

39.Water Activity (a{{w}}) in Foods39 Foods 4/16/84

40.Bacterial Endotoxins/Pyrogens40 Drugs and Devices 3/20/85

41.Expiration Dating and41

Stability Testing for Human Drug Products

Drugs 10/18/85

42.Tin Whiskers - Problems,42

Causes, and Solutions


43.Lyophilization of Parenterals43 Drugs, Biologics, Diagnostics 4/18/86

44.Radiation Protection Terminology44 Foods 5/15/86

45.Circular Temperature Recording45

Chart Measurements


46.Water for Pharmaceutical Use46 Drugs, Biologics, Medical Devices 12/31/86

47.Measurement of Relative Humidity47

in the ETO Process

Drugs and Medical Devices 4/30/87

48.Microbiological Contamination48

of Equipment Gaskets with Product Contact


49.Stock Rotomat49 Foods 5/30/87

50.Capacitor50 Medical Devices/RadiologicalHealth

10/23/87

51.Electronic Relays51 Medical Devices/RadiologicalHealth

11/10/87

52.Voice Recognition Systems52 GLP and Devices 11/10/87



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

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