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

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.

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.

Directors

Manager

Supervisors

Lead workers in Regulatory Affairs Quality Assurance and Quality Control

Workers who will prepare GMP documents for early phase products

Use coupon code NB5SQH8N and get 10% off on registration.

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

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.

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.

Directors

Manager

Supervisors

Lead workers in Regulatory Affairs Quality Assurance and Quality Control

Workers who will prepare GMP documents for early phase products

Use coupon code NB5SQH8N and get 10% off on registration.

 

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