This three-day course is designed to provide a basic understanding of the significant process development effort involved in taking an R&D laboratory formulation to commercial production. This course will focus on two main areas:
- How to develop a pilot process suitable for scale-up to commercial production.
- Factors to consider during scale-up and technology transfer to take a product from formulation development to the production floor.
The course will review topics such as process flow and equipment selection. Regulatory considerations, such as documentation and a need for pilot scale products to be representative of commercial production will be discussed. Various technologies available for manufacturing dosage forms will be reviewed in the context of scale-up parameters. These will include processing methods for mixing, granulation, compression and coating of solid dosage forms, as well as processing methods for solutions, emulsions, suspensions and sterile parenteral products.
Who Should Attend
This course is intended for personnel in process development, technical service and pilot plant groups within the pharmaceutical industry. This includes personnel responsible for manufacturing of dosage forms for clinical studies. It will also be of value to personnel in:
- Research & Development
- Analytical Services
- Product Development
- Manufacturing
- Production
- Quality Assurance
- Regulatory Affairs
- CMC Projects
The course is not designed to provide an in-depth review of science and technology of any specific process technology. Other courses offered by CfPA should be considered for that purpose.
Learning Objectives
Upon completion of this course, you will be able to:
- Determine the critical project management and regulatory issues to be considered for process development of dosage forms such as tablets, capsules, liquid orals, parenterals, scale-up of the process to manufacturing scale and transfer of technology from R&D to production
- Assess the associated regulatory issues, equipment selection, cost considerations, and critical need for coordination between R&D, Process Development, Production and Quality Assurance groups in the successful process development of drug dosage forms
Course Description
First Day
Review of Learning Objectives Process Development, Key Issues and Concepts
- Technical & Regulatory Considerations
- Project Management & Coordination
Factors to Consider in Process Development and Scale-up
- Quality by Design (QbD Concepts)
- Case Study
Solid Dosage Forms-Mixing, Granulation
- Equipment Selection
- In-process Tests
Solid Dosage Forms-Compression, Encapsulation, Coating
- In-process Tests
- Critical Process
- Attributes
Second Day
Liquids, Emulsions and Suspensions
- Disperse System Technology
- Milling and Mixing Equipment
- Critical Product & Process Parameters
- Equipment Selection
Parenteral Dosage Forms
- Small Volume Parenterals Scale-Up
- Development of Sterilization Processes
Lyophilization
- Scale-up Considerations
- Equipment Selection
- Sterile Validation
Pre Approval Inspection Preparation
- Audits
- Inspections
Evening Session-Review and Discussion with Faculty
- Participant Questions, Problems and Issues in Pharmaceutical Technology
Third Day
Clinical Supply Manufacturing
- Scale-up Considerations
- GMP Requirements
- Critical/Non-Critical Changes
Process Validation
- Planning, Coordination, Regulatory
Guidelines, Documentation Overview and Management of Product Process Validation
- Case Study
Technology Transfer to Production
- Documentation Package
- Equipment Selection
- Process Analytical Technology (PAT)
Assessment Opportunity
Course Directors
Mike Yelvigi is founder & principal at Center for Pharmaceutical Integration LLC, which provides consultation service to the industry in the area of CMC support &Technology Integration and Transfers (mergers & acquisitions). He retired as Sr. Director and Head of CMC Therapeutic Area Management function at Pfizer/ Wyeth Inc. NY. He had responsibility for co-ordination of CMC activities related to drug substance synthesis, drug product formulation, analytical development and regulatory filing for several therapeutic areas. He has over thirty years extensive experience in pharmaceutical formulation, process development/scale-up, process validation, manufacturing and pre-approval inspections and has successfully launched several products globally. He obtained his undergraduate degree in Pharmacy from Bombay University and graduate degree from Philadelphia College of Pharmacy.
He is an adjunct Assistant Professor of Pharmaceutics at the School of Pharmacy, University of Mississippi and an active member of AAPS, ISPE, AAiPS, FIP. He was the Chairperson of the AAPS Manufacturing Science & Engineering section and is also an Executive committee member of the Industrial Pharmacy Section of FIP. He is an editorial board member of Pharma Times journal.
Jay Rheingold, Founder of Drug Product Solutions, LLC, provides consulting on pharmaceutical development and manufacturing activities. Formerly, Dr. Rheingold served as VP, Pharmaceutical Development at Tobira Therapeutics and Barrier Therapeutics. Dr. Rheingold, received his B.S. in Biology from the State University of New York and his M.S. and Ph.D. in Pharmaceutical Sciences from the University of Connecticut.
Note: English will be used in all lectures and course notes.
