Prescription and OTC GMPs – Avoiding FDA Form 483 and Making the Best Decisions

In many countries around the globe, certain medicines with a long history of use are allowed to be sold over the counter (OTC) at certain doses without a prescription. So the safety and efficacy are well known from a public health/patient safety perspective, a contaminated OTC medicine could potentially impact a larger user population than a prescription medicine. In some countries, OTC manufacturers are treated the same way as other drug manufacturers – their products are after all medicines and are inspected to the same standards and at the same frequencies. In the U.S., OTC manufacturers must meet 21 CFR 210/211 and current good manufacturing practices (cGMPs).

Why You Should Attend:

Prescription and OTC cGMPs is a system for ensuring that products are consistently produced, packaged, tested and controlled according to current, established quality standards. The GMPs are designed to minimize the risks involved in any pharmaceutical operation. The GMPs cover all aspects of production from starting materials, facilities and equipment to training and personnel hygiene. This presentation is designed to detail the similarities and differences between GMP controls for Rx and OTC products.

Learning Objectives:

  • Learn to reduce the risk of FDA regulatory action
  • Learn to reduce the number and frequency of audits
  • Learn to ensure brand protection and integrity
  • How to avoid potential recalls and reduce risk to customers
  • How to improve quality of products sold to consumers
  • How to improve culture of quality in the organization and demonstrate a commitment to quality
  • Meet current expectations to stay ahead of your competition
Areas Covered in the Session :

  • Manufacturing, Packaging and Labeling procedures
  • Over-the-Counter (OTC) Monographs vs. NDA/ANDA cGMPs
  • Quality Systems
  • Production and process controls
  • Personnel qualifications and responsibilities
  • Cleaning procedures
  • Building and facility maintenance
  • Packaging and labeling procedures
  • Equipment validation
  • Holding and distribution
  • Laboratory operations
  • Recordkeeping
  • Product traceability
  • Identity testing
Who Should Attend:

  • Regulatory Affairs Departments
  • Quality Assurance Departments
  • Quality Control Departments
  • Compliance Departments
  • Research and Development Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Validation Departments
  • Product Development Departments
  • Documentation Departments
  • Risk Management Teams


Dr. Loren Gelber

Dr. Loren Gelber has more than 40 years of experience in pharmaceutical industry regulatory compliance. She worked for about 10 years at the FDA, including as a reviewer in the Division of Generic Drugs. She then transitioned to industry, working for four different pharmaceutical companies. For the last 13 years she has been a regulatory compliance consultant, both for consulting companies and independently.

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  • Presentation Handout in .pdf format
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