COURSE DESCRIPTION

OVERVIEW

The world of cleaning validation is undergoing a significant transformation related to how product and cleaning agent carryover limits are calculated.  The European Medicines Agency in their 2014, “Guideline on setting health based exposure limits,” is requiring the use of toxicologically derived limits for determining carryover.  Other industry agencies have also described their use in cleaning validation programs including International Society for Pharmaceutical Engineering (ISPE) and Active Pharmaceutical Ingredients Committee (APIC).  But how do companies interpret the regulations and expectations for their cleaning validation programs?  What happens if they do not consider the toxicological limits for their products from regulatory and science based perspectives?  What types of products does it apply to?  What is an ADE and PDE?  How and where does a company start?  Answers to these questions and much more will be discussed in this interactive course.

Another common cleaning validation gap is the need and benefit of a robust cleaning development program.  This discussion will focus on how to perform lab studies to identify critical cleaning parameters, and then how to apply the results to full-scale manufacturing equipment while optimizing the cleaning processes.   A good investment in this area will pay dividends for manufacturing companies for the life of the product.

Additionally, the lack of periodic monitoring of validated cleaning processes in the industry will be discussed.  This gap is significant and leads to regulatory issues and lack of assurance that the cleaning processes are in a state of control.  This course will discuss the two-part strategy using historical data and real-time testing to ensure compliance with the added benefit of determining the next monitoring point based on data.

LEARNING OBJECTIVES

Practical anecdotes and tips will be shared from lessons learned “in the trenches” executing cleaning programs at manufacturing companies.  Cleaning validation can be daunting, but through this course, information will be shared to impart confidence and direction.  You will also receive the following updates:

1. Impact from the recent EMA Q&A forum on cleaning validation – what you need to know
2. Global regulatory updates
3. Enforcement trends