Good Manufacturing Practices (GMP) 101

Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in each country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping. These requirements include the required education, training and experience for employees whose activities affect the quality of drug products. Among those educational requirements are a course in Introductory GMP upon employment at a pharmaceutical company, and annual refresher GMP training. 

The goal of this seminar is to enable you to:

• Demonstrate a basic knowledge of GMP requirements
• Interpret these requirements for your day-to-day operations
• Avoid the negative consequences of noncompliance
• Instill a culture of compliance in your organization

The subject of introductory GMP includes a discussion of the pivotal events that have shaped US laws on food, drugs and cosmetics; use of the terms GMP and cGMP (Current Good Manufacturing Practices); key sections in the US Code of Federal Regulations that impact drug manufacture; and how an organization can remain compliant with these regulations in their day-to-day operations.

• Quality Assurance Departments
• Regulatory Affairs Departments
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• Production Departments
• Packaging and Distribution Departments

DAY 1 (10 AM to 4 PM)

• Seminar objectives review, expectations and scope
• Interview attendees regarding their specific responsibilities and needs
• Agreement on focus

Session 2:

• Food and drug oversight
• Pivotal events that shaped laws in US and scope of FDA actions
• Examples of issues and regulations that they apply to

Session 3:

• Regulatory requirements for GMPs:
  • Quality Assurance
  • Training
  • Documentation
  • Laboratory Requirements
  • Facilities
  • Packaging and Labeling

Session 4:

• Consequences of noncompliance (including recent examples)
• Building a culture of compliance
• Review, Q&A

DAY 2 (10 AM to 4 PM)

Session 1:

• Seminar objectives review, expectations and scope
• Interview attendees regarding their specific responsibilities and needs
• Agreement on focus

Session 2:

• GMP vs. cGMP
• Compounding Facilities

Session 3:

• Emphasis on education and decision-making
• Training, memory retention, and accountability
• Notes on substandard product

Session 4:

• Onboarding new employees:
• Notes on Orientation
• Introductory GMP Training
• Curriculum Assignments

Session 5:

• Summary, Q&A, Knowledge check

Michael Esposito has over 30 years’ experience in the pharmaceutical industry and over 20 years’ experience in GMP training and document management. He has worked for Wyeth Pharmaceuticals, Pfizer and Johnson & Johnson's McNeil Consumer Healthcare Division in a variety of areas including Packaging, project administration, Quality Assurance, Government Contracts, translations, systems training, and international operations. He collaborated in the development and implementation of the training portion of the Consent Decree workplan for McNeil and revised their introductory GMP course. He is a member of the training organization Association for GxP Excellence (AGXPE) and is fully fluent in Spanish. His areas of interest include systems training, training effectiveness, post-training user support, process improvement, product security, and sustainable packaging.