"Approaches to Using Statistical Process Control Techniques for Continuous Monitoring of the Lyophilization Process"

Edward Trappler, President
ISLFD International Meeting
Havana, Cuba April 30, 2017

Monitoring Critical Process Parameters (CPP) and evaluating Critical Quality Attributes (CQA) for batch release is routine in commercial product manufacturing. Contemporary quality initiatives include the use of Statistical Process Control (SPC) for trending processes. Various approaches can be used for trending the CPP of the lyophilization process. This includes focus on the parameters as engineering units minimum, maximum and average, or variation from target, batch average, or historical average. Comparisons for variations could be for each process step, the entire process, or across multiple batches. This presentation will review the potential approaches, and highlight the benefits and limitations for each. Manufacturing process data for multiple batches of product will be presented to provide a comparison for trending and assess the effectiveness of each of the methods.


"Joint Interest Group Meeting: Visual Inspection of Parenterals and Lyophilization"

John G. Shabushnig, Insight Pharma Consulting, LLC and Edward Trappler, LTI
PDA Annual Meeting
Anaheim, CA April 5, 2017

With the introduction of USP chapter <1788> for difficult to inspect parenteral products, there has been significant discussions within the industry on considerations in sampling, utilizing the information within the USP chapter, and completing a suitable inspection. This joint session focused on considerations in utilizing the information embodied within the chapter for lyophilized products. The focus of this joint interest group session provided an open forum for lively and educated discussions on the USP chapter.

Should you be interested in reviewing a copy of either presentation, please contact us.

Richard (Rick) joined LTI as the Manager of Clinical Manufacturing in January 2017 and is excited to be a part of the team. He is responsible for working with and providing guidance to manufacturing staff and support to Project Directors and Quality Assurance for the production of Toxicology, Phase I and Phase II Clinical Trial Materials. 

Rick attended DeSales University where he obtained his Bachelor's in Business Management. Rick furthered his education in the Masters of Business Management and Leadership program at Capella University. 

Rick has more than 20 years in various management positions where he honed his skills in training and process improvement.

During his most recent tenure at Merck, West Point, he oversaw bulk manufacturing of Varicella vaccine.