cGMP Primer

cGMP Primer introduces the benefits and challenges of current Good Manufacturing Practices. The first section sets the stage with the regulatory bodies that enforce cGMP worldwide and the laws that pertain to it. This class takes a deep dive into the six cGMP pillar requirements, including Quality Management System (QMS), Premises and Equipment, Personnel Training, Materials Management, Documents and Records, and Validation and Qualification. This primer ends with a focus on regulatory audits, the Establishment Inspection Report (EIR), non-compliance, and remediations such as a 483. Two real-world case studies provide the opportunity to showcase your newfound knowledge by identifying the non-compliance and determining the corrective action. Take your spot for this introductory cGMP course!


Section 1: Understanding cGMP

Dive into the world of Current Good Manufacturing Practices (cGMP), exploring its significance, historical development, and global regulatory enforcement. Learn about cGMPs for various sectors, including biologics, medical devices, and blood products, while delving into implementation challenges and the benefits of global harmonization.

Section 2: cGMP Pillars 1-3

Explore the foundational pillars of cGMP compliance, covering Quality Management Systems (QMS) with a focus on document management and risk assessment, premises and equipment considerations including facility design and HVAC systems, and personnel training encompassing roles, qualifications, and safety protocols.

Section 3: cGMP Pillars 4-6

Learn more about the critical pillars of cGMP compliance, including Material Management with procurement and traceability, Documentation and Records maintenance emphasizing data integrity, and Validation and Qualification processes that ensure product quality across production stages.

Section 4: cGMP Non-Compliance

Gain insights into FDA inspections and outcomes, including classifications by product, FDA inspection reports, and common reasons for 483s, illustrated through real-world case studies of RemedyRepack Inc. and NeilMed Pharmaceuticals Inc.

Five Takeaways


  1. 1. Gain a comprehensive understanding of cGMP by exploring its definition, importance, and
    historical context.
  2. 2. Identify the global regulatory bodies that enforce cGMP and familiarize yourself with the laws and publications governing this crucial manufacturing practice.
  3. 3. State the specific requirements of each cGMP pillar.
  4. 4. Explain the challenges involved in implementing cGMP and list the strategies to overcome
  5. 5. Analyze real-world case studies to identify non-compliance issues and develop effective
    corrective actions to ensure compliance in manufacturing operations.

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