Good Manufacturing Practice


A GMP is a system for ensuring that products are consistently produced and controlled as per quality standards. It is designed to minimize the risks involved in any Food and pharmaceutical production that cannot be eliminated through testing the final product. GMP covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. 

Learning Objectives:

On completion of this course, participants will be able to:

  • Apply and discuss regulatory systems such as the quality system management, building and equipment requirements, personnel, material control, production controls, packaging and labeling systems, laboratory controls and good documentation practices
  • Examine and discuss GMP concepts beyond basic elements
  • Learn what Quality Systems Management is and how it effects your interpretation of the current regulations
  • Learn to properly discuss key GMP elements and learn the current interpretation and best practices based on the latest interpretation of regulations (understand the usual, customary practice)
  • Develop a specific GMP compliance plan and strategy for complying with the regulation
  • Define the concept of “usual and customary practice” and how it applies to regulatory inspections
Course Contents:
  • Quality Systems Management
  • Organization and Personnel Equipment
  • Control of Materials
  • Production Controls
  • Packaging and Labeling
  • Laboratory Controls
  • Documentation
  • Compliance Program Guidance

Key Contents:

  • The process approach used in quality management
  • The Model of a Process Based Quality Management System
  • The structure and content of ISO 9001
  • Quality Management Systems
  • The Audit Process
  • Auditor Activities
  • Audit Skills
  • Team Leading