GMP Expectations for Products Used in Early Phase IND Studies

This presentation will review the GMP guidance document and discuss how it may be integrated with the recommendations of the guidance documents on CMC requirements. 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.

FDA has issued a guidance document covering GMP requirements for products that will be used in early stage clinical studies. These guidelines are in addition to those that cover the CMC sections for IND submissions at Phase 1. The nature and extent of the GMP activities depend upon the nature of the investigational drug and the extent of the study that is planned. This presentation will review the GMP guidance document and discuss how it may be integrated with the recommendations of the guidance documents on CMC requirements.

Areas Covered in the seminar:

• Discussion of the elements to be found in the key 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.
• Which regulations come into play at different stages of product development.
• What to do about QC activities such as instrument qualification, method validation, and process validation.

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