Good, solid science has always been a key element in the regulatory environment for biologic products. The adage historically
applied to biologic products, "The process is the product," indicates process understanding is at least as important as product
characterization, if not more so. Regulators expect we know a great deal about our molecule and the specific process controls,
which assure its quality. Elements of risk-based decision-making are already defined by ICH for biologics in regard to raw
material controls, viral safety, and specifications. Thus, Q8 and Q9 offer more structure and specific tools to support good
scientific practices already in play for the development and control of biopharmaceuticals. The quality system elements under
development in Q10 may represent an opportunity for significant advances in the quality culture and spirit of continual improvement.
This article has described recent quality guidances that could lead to greater harmonization. The concepts of design space,
quality by design, process understanding, quality risk management, quality management, and continual improvement, all depend
on a solid scientific foundation. The application of these concepts in the current and future environment of biopharmaceuticals
There are several differences in the regulations. The specific and general requirements are somewhat consistent and differences
can be viewed as minor. The real differences lie within the details and interpretation of the regulations. This is where the
science embedded in the ICH Quality documents can help transcend regional differences and lead to scientific harmonization.
This is best captured in a quote attributed to the French microbiologist Louis Pasteur: "Science knows no country because
knowledge belongs to humanity and is the torch which illuminates the world."
ZENA G. KAUFMAN is director of the Quality Center of Excellence, Corporate Regulatory & Quality Science, at Abbott Laboratories, 100 Abbott
Park Road, Dept. 3QA, Bldg. AP6C, Abbott Park, IL 60064-6088, tel. 847.938.1750, firstname.lastname@example.org
DIANE BENO is director of Biologics Quailty Assurance.
1. Presentation by Dr. Emer Cooke at PDA Meeting December 2004, Paris, France.
2. Presentation by Dr. Joyce Ramsbotham, at PDA Meeting September 2003, Washington DC, USA.
3. International Conference on Harmonization Q8, Pharmaceutical Development.
4. FDA: "Risk-Based Method for Prioritizing cGMP Inspections of Pharmaceutical Manufacturing Sites—A Pilot Risk Ranking Model,"
5. Presentation by Mr. Gerry Migliaccio at PRPQA meeting, January 2006, San Juan, Puerto Rico.