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
Who will Benefit:
- 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
- 8:30 – 9:00 AM: Registration
- 9:00 – 10:30 AM: Good Manufacturing Practices & Phase 1 Requirements
- Core principles of GMP
- Detailed review of FDA phase 1 guidance document
- 10:30 – 10:45 AM: Break
- 10:45 – 12:30 noon: Good Manufacturing Practices & Phase 1 Requirements, continued
- Acceptable practices and practical tips
- GMP requirements for exploratory clinical studies
- 12:30 – 1:15 PM: Lunch
- 1:15 – 2:45 PM: Good Manufacturing Practices & Phase 1 Requirements, continued
- Personnel documentation and requirements
- Facility & equipment requirements
- Control of components
- Specific requirements for specialty products
- 2:45 – 3:00 PM: Break
- 3:00 – 4:00 PM: Vendor Selection and Management
- Planning for the early stage with an eye towards large scale manufacturing
- Vendor management
- Raw material handling issues for early stage products
- 8:30 – 10:00 AM: Overview of INDs Requirements & Expectations
- FDA requirements for an IND submission
- Expectations upon IND review
- Format and content of the CMC section of an IND
- 10:00 – 10:15 AM: Break
- 10:15 – 12:00 noon: Overview of INDs Requirements & Expectations, continued
- Characterization of the active ingredient and finished product
- Various kinds of products: drugs, biologics, botanicals, diagnostics, medical devices
- Manufacturing facility, personnel and equipment requirements
- 12:00 – 12:45 PM: Lunch
- 12:45 – 2:15 PM: Process Validation
- Introduction to process validation for early stage manufacturers
- Process validation reports and other documentation
- 2:15 – 2:30 PM: Break
- 2:30 – 4:00 PM: Creating SOPs Across all Stages of Development
- What SOPs are required during early clinical development
- When do additional SOPs need to be created
- Ensuring that appropriate SOPs are in place for contractors
- SOP processes and creation
- QC function and responsibilities
Peggy J. Berry
MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official)
Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book "Choosing the Right Regulatory Career" (RAPS, MD) and author of the 2011 book "Communication & Negotiation" (RAPS, MD).
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