Case Study

Successful Control Strategies – Part 1

Source: Cambrex

By Daniel L. Kirschner, PhD, Executive Director, Analytical Services, and Tom Lovelace, Sr. Manager, Process Development and Manufacturing, Cambrex

iStock-187467661-quality-control-inspection

Over the last decade, the FDA’s initiative to improve product safety through principles of Quality by Design (QbD) has spurred a transformation in manufacturing processes. The concept of using a control strategy to ensure product quality was originally devised to increase consumer safety, but following these guidelines also offers benefits to drug producers.

The application of QbD methods to process design yields better understanding of each step in product synthesis. With a complete picture of the parameters that control each step during manufacturing, chemists can monitor and control individual reactions to optimize the overall production process.

VIEW THE CASE STUDY!
Signing up provides unlimited access to:
Signing up provides unlimited access to:
  • Trend and Leadership Articles
  • Case Studies
  • Extensive Product Database
  • Premium Content
HELLO. PLEASE LOG IN. X

Not yet a member of BioProcess Online? Register today.

ACCOUNT SIGN UP X
Please fill in your account details
Login Information
ACCOUNT SIGN UP

Subscriptions

Sign up for the newsletter that brings you the industry's latest news, technologies, trends and products.

You might also want to: