GMP Expectations for Products Used in Early Phase IND Studies

Overview:

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
• Consultants