Quality Expectations for Drugs and Biologics during Early Development: Phase 3 and NDA

Even in Phase 3 clinical studies the requirements for the CMC section will not be identical as the requirements for marketed products. However it is important to set the stage for the routine production of a marketed product. The nature and extent of these activities depend on the type of drug and difficulties encountered in any scale-up processes. This presentation will discuss the quality-related activities that are expected for Phase 3 products used in clinical studies and the needs of the key demonstration lots that will be submitted with the NDA. Emphasis will be placed on the transition into full GMP work as clinical trials conclude. The requirements for NDAs (or BLAs) will be discussed. The quality elements for CMCs that are needed for Phase 3 clinical studies will be presented.

Areas Covered in the seminar:

• We will discuss the key guidance documents that will help to guide a company in the later stages of clinical trials and in the preparation of their NDA.
• Letting FDA help you in making your submission.
• What you need to do to prepare for Phase 3 and the NDA.
• Concerns if you are preparing a BLA.
• What to do about QC studies such as instrument qualification, method validation, and process validation.
• What do you need for the CMC section?
• Use of the Common Technical Document (CTD) to determine activities.

Who will benefit:

This presentation will be aimed at helping Regulatory, Quality Assurance and Quality Control personnel to understand the varying levels of quality activities that accompany early stages of Product development.

• Regulatory Affairs personnel who coordinate activities for the CMC sections of submissions
• QA/QC personnel who need to plan work
• R & D personnel who will contribute data to CMC sections
• Project managers for product development studies
• Quality systems auditors
• Consultants

Instructor Profile

Steven S. Kuwahara, Ph.D. is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories . He has participated in the product development process for small molecule drugs and biologics, and has prepared or reviewed many CMC sections.

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