FDA issued a guidance document covering GMP requirements for Phase 1
products. These guidelines remove some of the problems that are
encountered with early phase products and are in addition to those that
cover the CMC sections for IND submissions at Phase 1.
Although the guidance appears to remove the need to follow GMPs for
Phase 1 products, the need to follow GMPs is still present in the Food,
Drug, and Cosmetic Act. Thus the nature and extent of GMP-related
activities will depend upon the nature of the investigational drug and
the extent of the study that is planned.
Areas Covered in the Session
- Discussion of the elements found in the guidance document for Phase 1 material
- What to do at really early stages
- What about special IND studies?
- What about preclinical studies?
- Varying GMP activities that depend upon the nature of the IND product
- What are the requirements for the GMP found in the Food, Drug, and Cosmetic Act?
- What to do about QC activities such as instrument qualification, method validation, and process validation
Who Will Benefit
- Regulatory Affairs Personnel who Coordinate Activities for the CMC Sections of Submissions
- QA/QC Personnel who Need to Plan Work on Early Stage Material
- R & D Personnel who Will Contribute data to CMC Sections
- Project Managers for Product Development Studies
- Quality Systems Auditors
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 . Steve has participated in the development of drugs and biologicals through all phases of clinical research and final product production.