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

Event Information
Product Format
Prerecorded Event
Peggy J. Berry, MBA, RAC
Conference Date
Fri, Nov 17, 2017
90 minutes
Product Description

Explore FDA Guidance for Phase 1 Investigational Drugs

Current good manufacturing practices (CGMPs) for FDA Phase 1 clinical trials are a common source of questions for drug manufacturers. In Phase 1, drugs are given to humans, and there are a seemingly countless array of safeguards that the FDA requires in the process. Documenting CGMPs is an essential part of those safeguards.

This session by expert speaker Peggy Berry will overview the FDA’s current regulations and guidance documents for CGMP documentation in detail. She will discuss regulatory strategies and logistical considerations for drugs in their early development stages, and issues including vendor selection and management, stability, labeling and documentation requirements. After this session, you will understand the differences between CGMP requirements for early and later stage clinical development. You will also be able to develop and implement strategies for proper CGMP documentation.

Session Highlights

  • IND and NDA content and format for CMC information
  • Vendor selection and management for outsourcing early manufacturing
  • Raw material selections and considerations
  • Required SOPs and documentation

Session Agenda


Overview of drug development

o Section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351 (a)(2)(B)) requirements

• Overview of GMP requirements

o Discuss why certain requirements are not appropriate for investigational drugs used for phase 1 clinical trials

o The most critical areas of GMP compliance

• GMP requirements for phase 1 clinical trials

o Reduced GMP-compliance requirements for products intended for early phase clinical trial

o Requirement details contained in the FDA guidance document

o Standards for sterility and safety of investigational products must be always maintained

o The final product may be tested and released using analytical methods

• GMP sections 211.25, 211.28, 211.34, 211.63, 211.67, 211.80, 211.82, 211.84, and 211.100 requirements

• GMP requirements for phase 1 clinical trial materials

o Create a written plan describing the role for QC functions

o Eligibility criteria for all personnel

o Facility and equipment conditions

o Control of components, and containers and closures

o Maintain and follow written procedures of manufacturing and records

• GMP specifications for buildings and facilities

• Packaging, labeling and distributing requirements

Who Should Attend

  • Directors
  • Managers
  • Supervisors in Regulatory Affairs
  • Manufacturing Personnel
  • Quality Assurance Professionals
  • Clinical Operations Personnel

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Peggy J. Berry

Peggy J. Berry, MBA, RAC, is the president and 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, Peggy was Vice President of Regulatory Affairs at Insmed where she was responsible for the development and implementation of...   More Info
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