Quality by Design

Common challenges and key considerations when developing a freeze-drying cycle for protein pharmaceuticals.

Laser Diffraction Software Supports Analytical QbD

A study investigated the influence and correlation of critical process parameters for the optimization of in-process curing.

As Europe strives to firmly incorporate quality-by-design principles, there are several key issues that still need to be addressed.

Agencies extend successful pilot program to further harmonization of QbD topics.

Quality-by-design principles enhance a thorough understanding of both product and process technology, which is needed for optimization of solid-dosage manufacturing, including processes for improving solubility, such as hot-melt extrusion, softgels, and liquid-filled capsules.

Thirteen companies are accepted for participation in the supply chain program.

Traditional project decision-making is compared with a QbD approach.

A survey of BioPharm International readers found that single-use systems and other technologies are driving process efficiencies in biomanufacturing, but there is room for improvement.

PharmaCheck, a portable tool designed to detect poor-quality medicines, has been selected by Scientific American as one of the magazine?s World Changing Ideas of 2013.

Industry experts discuss the application, challenges, and benefits of a quality-by-design approach to sterile manufacturing.

Breakthrough Therapies Raise Manufacturing Issues

EMA and FDA publish joint QbD guidance on design space verification.

Siegfried Schmitt of PAREXEL discusses regulation requirements for quality systems.

The adoption of quality by design in small-molecule drug development and manufacturing continues to evolve as the industry seeks ways to augment process understanding for APIs.

Recent FDA enforcement activity reveals issues with vial-filling, adequacy of QA/QC procedures, particulate matter in inhalation powders and injectables, and drug labeling.

The adoption of quality by design in small-molecule drug development and manufacturing continues to evolve as the industry seeks ways to augment process understanding for APIs

Case studies on the manufacture of a bluk powder and the development of a tablet show the application of QbD principles.

Agencies collaborate to ensure consistent product quality.

Recent draft guidance from FDA on contract manufacturing and quality agreements highlights the importance of such agreements and define the roles and responsibilities of each party to be in keeping with quality risk-management principles.

Programs assist in the fast track of drugs for serious conditions.

Increased manufacturer outsourcing requires clear policies and written agreements with CMOs.

Making the effort to apply new methods to pharmaceutical processing will bring benefits.

Compositing samples is appropriate under certain circumstances but raises caveats on how and when it should be applied.

An introduction to the upcoming Interphex panel--Lessons Leaned: Successes and Challenges in Implementing Quality by Design.? Moderator: Jennifer Markarian, manufacturing editor, Pharmaceutical Technology. Panelists: John Lepore, senior director of Chemical Process Development and Commercialization for Global Pharmaceutical Commercialization at Merck and Co. Chris Moreton, FinnBrit Consulting Jonathon Thompson, senior manager of Compliance Services Consulting at Invensys Operations Management

Industry is moving toward closed-loop control of continuous processing.

The European Union authorities are stepping up their efforts to incorporate quality-by-design principles into their regulations and guidelines.

The authors present topics discussed and conclusions that resulted from the PDA QbD workshop.

Companies risk drowning in alphabet soup if the latest three-letter acronym improvement strategy isn't clearly linked to business strategy.

Applying quality-by-design and process analytical technology facilitates process understanding and control of various operations in lyophilization.