2021 - Managing GMP Compliance and Phase Appropriate GMP Considerations for Virtual Companies

Day 01(11:00 AM - 5:00 PM EDT)
Introduction and objectives
Virtual Company Challenges
Importance of quality management to business success
GMP defined and the Legal basis of GMP
Meaning of the term “Manufacturing”
CMO Role
Role of the contracting company
Specific GMP requirements that apply to virtual companies
Structuring a Quality Management System in a Virtual Company Setting
Structuring the organization and the Quality Unit
Structuring a document control hierarchy
Determining what procedures to have in place
Supply Chain Quality Management
Legal basis for this requirement of GMP
Vendor selection considerations
Quality Agreements
Vendor auditing system (frequency, depth, obstacles to overcome)
FDA Inspection Considerations
Types of inspections – GMP vs. PAI vs. Pre-License (BLA)
Readiness steps to consider
Day 02(11:00 AM - 5:00 PM EDT)
Phase Appropriate GMP Compliance
Legal basis
Applicability to placebos
FDA Guideline for Phase 1 GMP Compliance
FDA Guideline for Phase 2 and 3 GMP Compliance (legacy 1992 guideline no longer applicable to Phase 1)
EU Annex 13 – Investigational Medicinal Products
Importance of Data Integrity
GMP data versus “application data” and importance to PAI/PLI Success
Practical application of GMP principles to investigational drug manufacturing
Facility considerations – size, scale
Equipment qualification
Process and analytical method validation issues
Scale-up issues
Sterility and environmental control
Stability issues
Procedures – level of detail
Master and batch production and control records
Change control – at what point does this apply?
Deviation investigation
Batch disposition and role of the Quality Unit at the CMO vs the Virtual Company
Final discussion, Q&A