Quality Systems

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles

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

Tracking Quality in Drug Manufacturing

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

Quality by Design in APIs

Conrad Winters, PhD, is director, Drug Product Development Group, Hovione FarmaCiencia SA.

Filipe Neves, PhD, is group leader, Drug Product Development Group, Hovione FarmaCiencia SA.

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

Optimizing Quality by Design in Bulk Powders and Solid Dosage

Agencies collaborate to ensure consistent product quality.

FDA and EMA Publish Assessment of QbD for Marketing Applications

Recent draft guidance from FDA on contract manufacturing and quality agreements highlights the importance of such agreements and define the roles and responsibilities of each party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.

Defining Quality Agreements

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

FDA Creates Programs to Expedite Drug Development

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

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

FDA Urges Greater Focus on Contractor Quality

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

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

Experts at INTERPHEX Discuss Quality by Design

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

Compositing Samples and the Risk to Product Quality

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