Quality by Design Featured Articles

  1. How Reliable Is The Pharma Equipment You Buy? 8/13/2013

    When it comes to equipment manufacturing in the pharmaceutical industry, it is imperative that a product functions exactly as it was intended. Any misstep caused by faulty equipment could have catastrophic results for the company that produces a drug, but more importantly, for the patient who uses it. The serious consequences that can result from a lack of accurate equipment design and the associated manufacturing processes are why Donald Dobert, president and COO of ATL Pharmaceutical/Medical, created his company’s New Product Development (NPD) Planning Process.

  2. Best Practices For Designing Cell-Based cGMP Facilities

    CGMP regulations incorporate the concept of quality by design (QbD). This concept is used in conjunction with a quality management system (QMS) aimed at controlling the collection, processing, storage, and release of human medicinal products.

  3. Solving The OOS Problem With Continuous Manufacturing

    With continuous manufacturing, it is possible to monitor product quality continuously, and make adjustments in real time to keep the product in spec.

  4. Lean Six Sigma: Six Steps To Successful Implementation

    A focus on Lean Six Sigma manufacturing is instrumental to this company’s strategy for future growth and success.

  5. Incorporating Lean Principles Into Pharmaceutical QC Laboratory Design

    This article presents a case study based on an international workshop hosted by Novartis Vaccines to prepare guidelines for incorporating lean principles into pharmaceutical quality control laboratory design. By Mike Dockery, Federico Gabardi, Javier Garay, Jim Gazvoda, Luke Kimmel, Pietro Orombelli, Christophe Peytremann, Tom Reynolds, Tanya Scharton-Kersten, Graham Shoel, and Jeanne Sirovatka

  6. Defining Holistic Asset Criticality To Manage Risk In Biopharma

    This article presents how risks to safety, quality and productivity can be managed through asset control strategies, which are created based on specific asset criticality and failure modes.