The Inspection Technical Guides have been composed by FDA to provide their inspectors with technical information that has not been previously available on a broad scale. For medical translators and writers, these guides may serve as a source of background knowledge, descriptions of methods and equipment, and industry-standard terminology.
The complete list of Inspection Technical Guides includes 53 ITGs (as of January 2025).
The following guides apply to drugs, medical devices, or both:
- New Equipment Kenics Static Mixers
- Ethylene Oxide Sterilization 1. Calculation of Initial Gas Concentration
- Leak Testing Sealed Ampuls of Parenteral Solutions
- Polariscope
- Diathermy
- Steam Pressure for Retorts and Autoclaves
- Stroboscope
- Field Submission of Articles
- Common Valves Used in Process Fluid Systems
- A.T.I. Steam Activated Heat Sensitive Indicators
- New Source of Lead and Other Contamination
- Ultrasound in the Food, Drug, and Device Industries
- Screening Electronic Components
- Hermetically Sealed Electronic Component Leak Detection
- Noise Control Mufflers for Bleeders on Retorts and Sterilizers
- Ground Fault Circuit Interrupter
- The Computer in FDA Regulated Industries
- Air Velocity Meters
- Ethylene Oxide Sterilization 2. Graphical Aid to Determine Gas Concentration
- Evaluation of Production Cleaning Processes for Electronic Medical Devices - Part 1, Contaminants
- Evaluation of Production Cleaning Processes for Electronic Medical Devices - Part II, Cleaning Solvents
- Evaluation of Production Cleaning Processes for Electronic Medical Devices - Part III, Methods
- The Computer in FDA Regulated Industries - Part II Computer Hardware
- The Nation is Going Metric (rescinded)
- Electronic Components - Resistors
- Pyrogens, Still a Danger
- Use of the Texas Instruments Model 59 Programmable Calculator in the Enforcement of the Diagnostic X-ray Performance Standard
- Heat Exchangers to Avoid Contamination
- Reliability of Manufactured Products
- Reverse Osmosis
- Temperature Sensors in the Regulated Industry
- Industrial Applications of New Biochemical Technolgy
- Bacterial Endotoxins/Pyrogens
- Expiration Dating and Stability Testing for Human Drug Products
- Tin Whiskers - Problems, Causes, and Solutions
- Circular Temperature Recording Chart Measurements
- Water for Pharmaceutical Use
- Measurement of Relative Humidity in the ETO Process
- Microbiological Contamination of Equipment Gaskets with Product Contact
- Capacitor
- Electronic Relays
- Voice Recognition Systems
- Industry Assessment Guidance of Medical Products for Defense Logistics Agency Contracts