Pharmaceutical Process Development

Mukund (Mike) Yelvigi

Course description

This 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:

1. How to develop a pilot process suitable for scale-up to commercial production.
2. 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.

This training is ideal for those new to this area but will also benefit those who are experiencing problems with existing development or process activities.

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