Mapping a Pharmaceutical Ingredient Bulk Manufacturing Workflow

This course will describe the basic elements of pharmaceutical ingredient bulk manufacturing and give you the tools that can help you develop a new workflow or improve upon an existing workflow.

• Describe general information related to the manufacture of active pharmaceutical ingredient (API).
• Outline the factors to keep in mind when manufacturing certain drug types (e.g., penicillin).
• Describe the parameters of laboratory testing and Quality Assurance acceptance or rejection of batches.
• Articulate the types of defects that can exist with tablets, capsules, and other dosage forms.
• Account for specific reasons for deficient product and means of resolution
• Consider the requirements for warehousing once API is produced.
• Review workflows once created and documented to achieve process improvements.

• Overview of API production
• API in the context of project management
• Drug types that warrant special consideration
• Laboratory testing and possible product defects
• Batch review and approval/rejection
• In-house labeling and warehousing of API
• Packaging and distribution of bulk product
• Bulk product intended for creating finished package

This course will be of benefit to employees who are tasked with creating new manufacturing workflows or revising existing workflows for APIs. People working in Pharmaceutical industry, Manufacturing, Change Control, Laboratory testing, Quality Assurance, Packaging and Labeling, Inventory Management, Warehousing and Distribution will also benefit from taking this training.

Instructor Profile:

Michael Esposito

Principal, TrainReach Consulting, LLC

Michael Esposito has over 30 years’ experience in the pharmaceutical industry and over 20 years’ experience in GMP training and document management. He has worked for Wyeth Pharmaceuticals, Pfizer, and Johnson & Johnson's McNeil Consumer Healthcare Division in a variety of areas including Packaging, project administration, Quality Assurance, Government Contracts, translations, systems training, and international operations. He collaborated in the development and implementation of the training portion of the Consent Decree work plan for McNeil and revised their introductory GMP course. He is a member of the training organization Association for GxP Excellence (AGXPE) and is fully fluent in Spanish. His areas of interest include systems training, training effectiveness, post-training user support, process improvement, product security, and sustainable packaging.