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[FDA] Inspection Technical Guides (ITGs)

Описание

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  • The Nation is Going Metric (rescinded)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


Обновлено 16 января, 2025

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