The Importance of Packaging and Labeling in Pharmaceutical Product Development

Pharmaceutical and life sciences companies are under an extreme amount of pressure to maintain an ever-increasing amount of regulation and legislation. With this pressure, they still need to increase efficiencies, bring new products to the market faster, reduce prices, deliver innovation, ensure patient compliance, and maintain business compliance.

After completing this course, you’ll be able to:

• Articulate Packaging and Libeling’s role in product development
• Ensure adherence to regulatory agency requirements
• Anticipate potential obstacles in marketing, medical affairs, regulatory, legal, or quality assurance
• Work effectively with contract manufacturers or packagers
• Manage labeling in foreign languages
• Avoid unnecessary production costs, backorders, and recalls, especially during product launches

• Regulatory Agency Requirements
• SOPs and Change Control considerations related to packaging
• Packaging and Labeling Interactions
• Creation of the Package
• Codes
• Packaging Errors
• Labeling Errors
• Supply Chain Issues
• Special Considerations (e.g. product launches, clinical vs. commercial packaging)

Occupying a critical position in the success or failure of any pharmaceutical product launch, Packaging and Labeling form a bridge between the conception of a product and its realization and distribution. Their activities are also crucial for compliance with regulatory agency requirements.

Still, their importance is often underestimated, especially in the planning phases, which leads to unnecessary increases in cycle time, costly errors, delays in product availability, or product recalls due to noncompliance. Understanding the packaging and labeling process in the larger product development process will provide you with an advantage in achieving success.

• Marketing
• Project Management
• Operations
• Regulatory Affairs
• Labeling and Packaging
• Quality Assurance
• Production Control
• Packaging Technology
• Labeling Coordination
• Package Engineers
• Packaging Operations
• Sales and Marketing
• Quality Assurance Consultants
• Research and Development

Michael Esposito has over 30 years’ experience in the pharmaceutical industry and 17 years’ experience in GMP training and document management. He has worked for Wyeth Pharmaceuticals, Pfizer, and Johnson & Johnson's 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 Johnson & Johnson Consumer Healthcare and revised their introductory GMP course. He is a member of the training organizations GMP Training Educators Association and Association for GXP Excellence 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.