Occupying a critical position in the success or failure of any pharmaceutical product launch or revision, 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. The importance of Packaging and Labeling is often underestimated, especially in the planning phases of product and package development, which leads to unnecessary increases in cycle time, costly errors, and delays in product availability, or product recalls due to noncompliance. Many packaging and labeling errors are possible because the information that appears on each package comes from different sources and is subject to frequent changes, often in the middle of the packaging development process. The process thus requires diligence and attention to detail by packaging and labeling employees. These considerations become even more important during a product launch because of the criticality of meeting the launch date and the uncertainties surrounding regulatory agency approval or last-minute requests for changes.

After completing this course, you will be able to:

• Articulate Packaging and Labeling’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

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. Understanding the packaging and labeling process in the larger product development process will provide you an advantage in achieving success because your knowledge of the processes and ability to articulate them to your colleagues will give you the leverage to resolve potential and actual roadblocks and enable you to advocate for attention to detail while respecting schedules.