Quality Systems

Agnes Shanley is senior editor of Pharmaceutical Technology.

Articles

Industry practice has changed radically over the past five decades. Can laws published in the 1960s still ensure pharmaceutical quality and safety today?

Is it Time to Update cGMPs?

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

The US Senate and the US Pharmacopeial Convention debate the necessity of monographs for biologics. 

FDA Challenges USP Standards for Biologics

Using Lean, Six Sigma, and other Op Ex practices is helping one contract development and manufacturing organization (CDMO) increase efficiency and optimization.

Applying Operational Excellence to Improve Injectable Pharmaceuticals Production

FDA sent a warning letter to Spectrum Laboratory Products, Inc. after an inspection found CGMP and misbranding violations.

California Facility Receives FDA Warning Letter

The company is voluntarily recalling all unexpired products that are intended to be sterile because of a lack of sterility assurance.

Premier Pharmacy Labs Recalls All Unexpired Sterile Products

Vida International received an FDA warning letter after an inspection found quality control violations.

Taiwan Facility Receives FDA Warning Letter

The two countries have been included into the mutual recognition agreement between the European Union and the US FDA that recognizes facility inspections conducted in different territories. 

Luxembourg and the Netherlands Added to EU–US Inspections Agreement

Kingston Pharma LLC received a warning letter after an FDA inspection found violations of current good manufacturing practices including inadequate quality control.

New York Facility Receives FDA Warning Letter

A US District Judge in the Southern District of Florida held that the US Stem Cell Clinic of Weston, FL and US Stem Cell of Sunrise, FL adulterated and misbranded a stem cell drug product made from a patient’s adipose tissue.

Federal Court Decides US Stem Cell Clinics Adulterated and Misbranded Products

Although continuous approaches offer significant benefits for some products and processes, batch manufacturing is not going away any time soon.

Quality Assurance/Quality Control