Mapping a Pharmaceutical Ingredient Bulk Manufacturing Workflow

Mapping and evaluating all the steps in a current pharmaceutical ingredient bulk manufacturing workflow can lead to valuable process improvements. In this webinar, we discuss how this review can be accomplished and the possible benefits that can result.

Why should you Attend:
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.

Key learning objectives of the topic:

• 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