Scale-Up and Post Approval Changes Guidelines (SUPAC & API Changes)
This course is not currently scheduled. Click on the Notify Me button to the left to be notified when it is scheduled.
This course is available as a client site course. Please click here for more information.
Who Should Attend
This course is intended for personnel in the pharmaceutical
industry involved in the development of drug dosage forms
including:-
Process Development
- Technical Service
- Pilot Plant
- Quality Assurance
- Regulatory Affairs
- Research & Development
- Production
It will also be of value to personnel wanting a comprehensive
understanding of FDA guidelines and requirements relevant to
changes in formulation, equipment and process in the following
fields:-
Analytical Services
- Product Development
- Production
- Quality Assurance
- Project Management
Description
This course will provide a basic understanding of the FDA
Scaleup and Post Approval Changes Guidelines & the recent
2004 guideline on Changes to approved NDA or ANDA. This
also addresses the impact of withdrawal of the FDA BACPAC I
guideline on changes in API synthesis. The issues affecting batch
size scaleup/scale-down, various post approval formulation
component or composition changes, site of manufacturing
changes, manufacturing process changes, and/or equipment
changes will be addressed along with the issues affecting
analytical methodology, packaging and labeling changes.
The course will focus on:
- The criteria that determines the level or degree of change.
- The type of study data or information that must be generated to support changes at each level.
- The FDA recommended chemistry manufacturing & control
tests to support each level or degree of change.
- The type of in-vivo or in-vitro testing required to support the various levels of degrees of change.
Case examples will be employed to allow the students to
determine the type of data that are required to support the level
of changes proposed.