FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials

Because a phase 1 clinical trial initially introduces an investigational new drug into human subjects, appropriate CGMP help ensure subject safety. It is important to implement quality control (QC) principles to the manufacture of phase 1 investigational drugs (i.e., interpreting and implementing CGMP consistent with good scientific methodology), which foster CGMP activities that are more appropriate for phase 1 clinical trials, improve the quality of phase 1 investigational drugs, and facilitate the initiation of investigational clinical trials in humans while continuing to protect trial subjects.

The following steps to establish the appropriate manufacturing environment for phase 1 investigational drugs should be taken:

• A comprehensive and systematic evaluation of the manufacturing setting (i.e., product environment, equipment, process, personnel, materials) to identify potential hazards
• Appropriate actions prior to and during manufacturing to eliminate or mitigate potential hazards to safeguard the quality of the phase 1 investigational drug

Review the FDA recommendations and requirements for implementing a compliant program for the phase 1 clinical program.

The following topics will be discussed to provide the foundation and basis for advancing drugs into clinical development from research and providing required information to the FDA regarding these products.

• Overview of Good Manufacturing Practices
• GMP Requirements for a Phase 1 Study
• Personnel
• QC Function
• Facility and Equipment
• Control of components, containers and closures
• Manufacturing & Records
• Laboratory Controls
• Vendor selection & management
• Process Validation
• Special Considerations
• Multi-product facilities
• Biologics
• Sterile products
• Combination products
• Providing relevant information in the IND application

Course benefit:

This workshop will review the current regulations, guidance documents for early stage manufacturing and GMPs in detail. Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labeling, and documentation requirements will also be reviewed and explored.

Learning Objectives:

To gain an understanding of the requirements for drugs entering into phase 1 clinical development and the minimum FDA requirements for phase I GMPs. To learn practical applications for implementing manufacturing and quality strategies to meet FDA requirements.