Issues

Quality

Key Points

A generic is the same medicine as its brand counterpart and has the same product attributes as the brand. Specifically, generics are the same in terms of dosage, safety, strength, directions for administration, quality, purity, performance and intended use. In other words, generic medicines provide the same medicine, and same clinical benefits at more affordable prices.

Regardless of whether your medicine is brand or generic, FDA requires every FDA-approved prescription drug to meet the same rigorous quality standards for product identity, strength, and purity. Further, FDA regulated drug products are required by federal law to be manufactured under FDA’s strict standards for good manufacturing practices.

Background

One of the main goals of the generic pharmaceutial industry is ensuring the quality of its products. The generic industry follows the same concepts and principles set by the FDA, incorporating the concept of "Quality of Design" or QbD as a core tenet in production and manufacturing. QbD is an important reason why generic manufacturers continue to produce high-quality medicines for all consumers.

Science and quality are the cornerstones of the generic pharmaceutical industry. Against this backdrop, members of the generic pharmaceutical sector consistently make substantial investments in manufacturing facilities, critical building and testing infrastructure and operations to ensure product integrity, quality assurance and quality control. In fact, generic manufacturers operate some of the most state-of-the-art facilities in the world. In order to maintain the highest quality of medicine, GPhA strongly supports strict enforcement of the most rigorous good manufacturing requirements as set and overseen by FDA.

Specifically, the generic industry utilizes a modern, scientific and risk-based pharmaceutical quality system as part of its commitment to quality. Like the brand industry, generic manufacturers embrace FDA’s concepts and principles set forth in Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach and the Process Analytical Technology initiative that help assure product quality through design and performance-based specifications.

One of the key concepts of pharmaceutical product quality is the concept of "Quality by Design" (QbD). This means that quality is built into a product with a thorough understanding of the process by which it is developed and manufactured, and a keen awareness of both the risks involved in manufacturing the product and the best ways to mitigate those risks. QbD provides the scientific structure to understand all critical aspects of a drug formulation and manufacturing process. This approach of ‘building in’ quality for every product based on quality by design allows manufacturers and consumers alike to be certain that the most accurate and precise specifications are maintained for each batch of medicine. QbD also enables pharmaceutical manufacturers to reproduce the highest quality product from batch to batch and year to year.

Related Information

Testimony & Content

May 18, 2005 - GPhA Testimony before the House Energy and Commerce Committee on Generic Utilization