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The US Food and Drug Administration (FDA) has detailed regulations for pharmaceutical Good Manufacturing Practice (GMP).  These regulations describe in general terms the minimum requirements for preparation of over-the-counter (OTC) and prescription (Rx) drug products.  These regulations are divided into 11 major subparts, each of which has various subparts.  All employees of pharmaceutical manufacturing firms are required to be trained in and to know the GMP regulations that are relevant to their job functions.


  • Understand General Provisions
  • Review Organizations and Personnel
  • Requirements for Buildings and Facilities
  • Requirements for Equipment
  • Understand Control of Components
  • Understand Control of Packaging Components
  • Requirements for Production and Process Controls
  • Requirements for Packaging and Labeling Controls
  • Review Holding and Distribution
  • Understand Data Integrity Requirements
  • Review Laboratory Control Requirements
  • Review Records and Reports
  • Understand Returned and Salvaged Drug Products

  • General Provisions
  • Organizations and Personnel
  • Buildings and Facilities
  • Equipment
  • Control of Components
  • Control of Packaging Components
  • Production and Process Controls
  • Packaging and Labeling Controls
  • Holding and Distribution
  • Data Integrity Requirements
  • Laboratory Control Requirements
  • Records and Reports
  • Returned and Salvaged Drug Products
  • FDA Inspections
  • FDA Warning Letters and 483s re GMPs

  • Regulatory affairs managers, directors and associates
  • Compliance specialists
  • Quality professionals
  • Internal and External trainers

  • GMP Trainers
  • Quality Supervisors and Managers

Dr. Loren Gelber is currently an independent consultant, based in Charlotte, NC.She previously was employed by Akesis, Bestsweet, RRI, Andrx, Royce, Universal Research, Danbury Pharmacal, Barr and the US FDA. She has been in Regulatory Compliance, Regulatory Affairs, Clinical Research and Quality Control Laboratories.

Dr. Gelber has a Ph.D. in Medicinal Chemistry from Northeastern University, a Masters in Chemistry from Brooklyn Polytechnic and a Bachelors in Biology from Brandeis University. 

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Nov. 1, 2024

Human Factors Usability Studies Following ISO 62366 and FDA Guidance

Edwin Waldbusser

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