Whitney Winters

Director, Sales, Emering Biologics

十二月 02, 2013

Why is QbD so Confusing?

QbD, CQA, QTPP,FEA – what does it all mean? Quality by Design (QbD) can be confusing, but it really doesn’t have to be. QbD was designed to promote an understanding of the product and manufacturing process starting with product development. When designing and developing a product using QbD principles, manufacturers must define desired product performance and identify Critical Quality Attributes (CQAs). The product and process is then designed to meet those product attributes, which leads to understanding the impact of material attributes and process parameters on the CQAs and identification and control of sources of variability. As a result of this knowledge, a company can continually monitor and update its manufacturing process to assure consistent product quality.

A Quality Target Product Profile (QTPP) is used to establish CQAs. When West decided to create a new syringe plunger it created a QTPP with a CQA for control of breakloose and glide forces.   Development of the NovaPure® plunger  included risk-based design inputs, Finite Element Analysis (FEA) modeling, data generation on multiple concepts, and final product performance verification with glass barrels from multiple suppliers of a 1mL long staked needle syringe.   Throughout the development process QTPP served as a guideline to assure that targeted specification values for breakloose and glide force were met. Using QBD philosophy and principles can help to optimize breakloose and glide forces and significantly reduce plunger variation from part-to-part

Use of QbD principles ensures that components are developed based on science and data-driven decisions, and meet critical specification for defects, visible and sub-visible particulate and extractables consistently. In order to achieve a high-quality product, QbD components are washed and steam sterilized for optimized material compatibility and the knowledge gained throughout the process is used to maintain continuous improvement by the manufacturer. Selecting a manufacturing partner like West early in the development process can help pharmaceutical companies choose a high-quality component for use in prefillable syringe systems that will meet demands for high quality, improved total cost, and increased safety and security for the drug product.

NovaPure® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.