Biotility: CGMP for Biopharmaceutical Drug Products

The first module of the course reviews the basics of the Current Good Manufacturing Practices (CGMPs). It covers the purpose of CGMPs, critical elements of control, and good documentation practices.

Recommended Use: Required
ID (Language): 21485 (English)
Author(s): Stephanie DeMarco, MA - Biotility at the University of Florida; Jennifer Hughes, MAg - Biotility at the University of Florida

This module introduces the role of the FDA, including which products are regulated and the different FDA lead centers. The module also overviews the history of CGMP regulations and explains the role of industry guidance documents.

Recommended Use: Required
ID (Language): 21486 (English)
Author(s): Stephanie DeMarco, MA - Biotility at the University of Florida; Jennifer Hughes, MAg - Biotility at the University of Florida

This module covers the five major departmental roles in CGMP-compliant manufacturing. It further covers how the departmental roles may interact and overlap in different organizations and emphasizes the importance of defined responsibilities and communication.

Recommended Use: Required
ID (Language): 21487 (English)
Author(s): Stephanie DeMarco, MA - Biotility at the University of Florida; Jennifer Hughes, MAg - Biotility at the University of Florida

This module covers the first three fundamentals of CGMP compliance that need to be addressed prior to the manufacturing process. These include training, personnel, and communication; written procedures, documentation, and record keeping; and facility controls.

Recommended Use: Required
ID (Language): 21488 (English)
Author(s): Stephanie DeMarco, MA - Biotility at the University of Florida; Jennifer Hughes, MAg - Biotility at the University of Florida

This is the second of a three-part review of the ten CGMP fundamentals. In this module, the fundamentals covered include those that generally focus on the control of the biomanufacturing process itself. This covers the production and process controls, operation controls and validation, maintenance and calibration, and contamination controls.

Recommended Use: Required
ID (Language): 21489 (English)
Author(s): Stephanie DeMarco, MA - Biotility at the University of Florida; Jennifer Hughes, MAg - Biotility at the University of Florida

The final module of this course wraps up the three-part series by covering the three fundamentals which generally focus on regulatory compliance and marketable product. This includes control and identification of materials; final product specifications; labeling, holding, and shipping; and, change controls.

Recommended Use: Required
ID (Language): 21490 (English)
Author(s): Stephanie DeMarco, MA - Biotility at the University of Florida; Jennifer Hughes, MAg - Biotility at the University of Florida