Elements of a quality assurance program for pharmaceutical research & development¹

I wish to thank Dr. John Donahue, Vice‐President, Worldwide Regulatory Compliance, SmithKline Beckman Corporation, for his many helpful comments, suggestions, and editorial services.

Abstract

The four major considerations for a pharmaceutical R&D quality program are discussed—protection of resources, compliance, documentation, fitness for use. Viewing R&D as an enterprise necessitates that R&D be seen as making products—data, analysis and interpretation. The applicability of the quality program to these products is discussed.

Keywords:

• quality
• assurance
• compliance
• data
• development

Notes

I wish to thank Dr. John Donahue, Vice‐President, Worldwide Regulatory Compliance, SmithKline Beckman Corporation, for his many helpful comments, suggestions, and editorial services.