Active Pharmaceutical Ingredients Production

Pilot and commercial production
QA/QC
Regulatory affairs
Process development
Engineering
Management

The course models a GMP compliant API operation, everyone’s role in achieving compliance, and penalties for noncompliance. Government investigators who inspect API operations are encouraged to attend.

Description:
This course prepares attendees to meet the challenges they face in this heavily regulated industry. It is vital for API producers to ensure that GMP principles are applied to API production and control, and to demonstrate knowledge of FDA, ICH and other governmental and industry guidance documents.

This course will provide guidance in the design, construction, and validation of GMP pilot and production facilities. Examples of facilities will be discussed. The selection, qualification, and cleaning of equipment will be included with specific examples. Process validation is of singular importance and validation principles and their application will be demonstrated with examples. Process development and technical transfer reports will be described. The function of the quality unit to establish and manage the systems required to maintain compliance will be discussed. Throughout the program there will be interactive class exercises. On the last day of the course participants will receive instruction on managing an FDA inspection followed by a workshop in which participants prepare written responses to simulated FD-483s (List of Inspectional Observations) based on actual FDA observations. The exercise will result in a valuable exchange of information and approaches with your colleagues.