This program combines general considerations for Good Manufacturing Practice (GMP) compliance management with the principles of phase-appropriate GMP considerations, with an emphasis on needs of virtual companies. (“Virtual companies” are those which outsource GMP operations to Contract Manufacturing Organizations (CMOs) and Contract Analytical Laboratories.)
Virtual companies typically do not conduct “hands on” manufacturing, but do perform tasks which are governed by GMP, for example, dispositioning final product, managing the supply chain, investigating complaints, and providing training to staff in GMP compliance concepts. Such companies often struggle to decide how to structure their quality management system, which procedures they need or do not need, and how to best manage vendor relationships.
In addition, the application of GMP requirements to the manufacture of investigational products requires exercise of judgment over the life cycle from early phase (Phase 1) to peri-approval (late Phase 3). Understanding what is required by FDA and other regulatory agencies is important to assure timely approval, since GMP compliance issues can result in approval delays.
In this two day workshop you will learn how GMP applies directly to virtual company operations, how to best structure a quality management system in a virtual company, and a method to decide which procedures are necessary at what points in time. You will also learn best practices for quality agreements and vendor management. In addition, you will learn the current guidance from FDA for application of GMP to the manufacture of Phase 1, 2 and 3 clinical trial materials. Though FDA requirements are the primary emphasis, some discussion of EMA (European) requirements and other venues will also be included.
Learning Objectives:
Upon completing this course participants should:
- Understand the fundamentals of GMP for the United States
- Understand how to determine what GMP-governed operations you are performing internally versus what you are outsourcing
- Understand a method to structure your quality management system and decide which procedures you need now versus which ones can wait
- Understand best practices for vendor management
- Learn how to apply GMP concepts to Phase 1, 2 and 3 investigational drugs
- Learn the differences between an FDA GMP inspection, a Pre-Approval Inspection and a Pre-License Inspection and where to obtain guidance for each
- Understand basic principles of FDA inspection authority, what to expect if FDA inspects your virtual firm, and how to manage the presence of FDA personnel on site
Agenda:
DAY 1 (9:00 AM PT TO 4:00 PM PT)
- 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 2 (9:00 AM PT to 4:00 PM PT)
- 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
Instructor Profile:
David L Chesney
Principal and General Manager, DL Chesney Consulting, LLC (Former FDA Director)
Principal and General Manager, DL Chesney Consulting, LLC (Former FDA Director)
David L. Chesney, MSJ, is the Principal and General Manager for DL Chesney Consulting, LLC, providing GMP and GCP compliance consulting and training services to clients world wide. He has 47 years experience, evenly divided between the FDA and the private sector, including over 20 years as Vice President, Strategic Compliance Services for PAREXEL Consulting.