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

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Directors, Manager, Supervisors, Lead workers in Regulatory Affairs Quality Assurance and Quality Control, Workers who will prepare GMP documents for early phase products, Workers who will review GMP documents for early phase products

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Seminar Summary:

Because a phase 1 clinical trial initially introduces an investigational new drug into human subjects, appropriate CGMP help ensure subject safety. (see full course description)

 

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Training Course Syllabus:


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

Course Description:

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.

Areas Covered:

Day 1 Topics

Overview of GMP requirements
GMP Requirements for a Phase 1 Study
Personnel documentation and requirements
QC Function procedures and requirements
Facility and Equipment requirements
Control of components, containers and closures – methods and specs
Manufacturing & Records during phase 1 studies with an eye toward later development

Day 2 Topics

Vendor selection & management
Process Validation to conduct for phase 1 clinical supply process
Specific requirements for various types of products: biologics, combinations, sterile products
Multi-product facilities considerations
Preparing relevant SOPs for early stage development
Providing relevant information in the IND application

Course Outline:

DAY ONE (8:30 AM – 4:00 PM)

Registration Process: 8:30 AM

Day 1 (ISO 9001:2015 QMS related)

8.30 am – 10.30 am: Moving a Product out of R&D
Issues with research grade material used for laboratory and non-clinical testing
Optimizing manufacturing processes
Raw material requirements and process development
Assessing scalability of manufacturing
Planning the CMC for a potential IND
10.30 am – 10.45 am: Break
10.45 am – 12.30 pm: CMC Requirements for an IND Study
Essential elements of the CMC section of an IND
Characterization of the active ingredient and finished product
Various kinds of products: drugs, biologics, botanicals, diagnostics, medical devices
Manufacturing facility, personnel and equipment requirements
12.30 pm – 1.15 pm: Lunch
1.15 pm – 2.45 pm: Good Manufacturing Practices: Basics for Beginners
Core principles of GMP
Regulatory requirements for different products: drugs to medical devices
Customizing regulatory compliance to a given product
Role of discussions with the FDA
2.45 pm – 3.00 pm: Break
3.00 pm - 4.00 pm: Raw Material Management
Planning for the early stage with an eye towards large scale manufacturing
Vendor management
Raw material handling issues for early stage products
Manufacturing step development

DAY TWO (8:30 AM – 3:30 PM)

8.30 am – 10.00 am: GMPs for Phase 1 IND products
The scope of the FDA guidance document
Acceptable practices and practical tips
GMP requirements for exploratory clinical studies Specific requirements for drugs, biologics and combination products
10.00 am – 10.15 am: Break
10.15 am – 12.00 pm: GMPs for Combination Products and 505(b)(2) Products
Specific issues for various kinds of combination products
Combination products with one or more new components
CMC issues for 505(b)(2) products
GMP and QSR: which to follow for a combination products
12.00 pm – 12.45 pm: Lunch
12.45 pm – 2.15 pm: Process Validation for Early Stage GMP
Introduction to process validation for early stage manufacturers
Step by step instructions for process validation
Process validation reports and other documentation
Developing SOPs based on validation processes
2.15 pm – 2.30 pm: Break
2.30 pm – 3.30 pm: Outsourcing Early Stage Manufacturing
Logistics of using contract manufacturing organizations for early stage products
Pilot scale manufacturing requirements
GMP-grade and non-GMP grade manufacturing
Benefits and challenges with using local and international vendors

Seminar Summary:

Because a phase 1 clinical trial initially introduces an investigational new drug into human subjects, appropriate CGMP help ensure subject safety. (see full course description)

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