GMP Compliance During Development

Abstract

Requirements for assuring Good Manufacturing Practices (GMP) compliance during the development of active pharmaceutical ingredient (API) processes and the preparation of APIs for clinical use present a significant challenge to development scientists. Development environments are characterized by frequent changes during optimization activities; specifications, process conditions, and scale continue to be modified as any product approaches approval. Until recently, available guidance was silent on GMP considerations for APIs used during clinical studies. Just as the spectrum of GMP considerations for API processing imposes increasing scrutiny from initial intermediates through the final active ingredient, escalating requirements exist for API process development from the first lot to the biobatch or pivotal trial material. Industry perspectives on appropriate controls for these interdependent GMP considerations will be discussed.