Quality Assurance/Quality Control

USP Celebrates its 200th Anniversary

January 09, 2020

The company has various projects and launches scheduled for 2020 as part of its anniversary celebration.

FDA Emphasizes Importance of Quality Unit in Warning Letter

January 03, 2020

The agency sent a warning letter to Henan Kangdi Medical Devices Co. Ltd after an inspection found CGMP violations that included a variety of failures of the company’s quality unit.

India Facility Receives Warning Letter

January 02, 2020

FDA sent a warning letter to GPT Pharmaceuticals Pvt. Ltd. after inspectors found CGMP violations that included equipment that was not properly maintained.

Mirtazapine Tablets Recalled

January 02, 2020

Aurobindo Pharma USA, Inc. voluntarily recalled Mirtazapine Tablets due to an error on the label that listed the incorrect strength.

Getting to the Root of Quality Problems

January 02, 2020

Focusing on symptoms instead of root causes locks teams into a corrective, rather than preventive, mindset.

Real-World Vapor Phase Hydrogen Peroxide Decontamination

January 02, 2020

Past mistakes and misstatements have adversely influenced industry decontamination practices with vapor phase hydrogen peroxide, and this article endeavors to clarify the process.

Devices Under Scrutiny

January 02, 2020

Without careful consideration and understanding, new regulations for medical devices could lead to the withdrawal of combination products from the market.

Glenmark Pharmaceuticals Recalls Ranitidine Tablets

December 18, 2019

Glenmark Pharmaceuticals is recalling unexpired lots of Ranitidine Tablets due to potential presence of N-nitrosodimethylamine (NDMA).

Pennsylvania Facility Receives Warning Letter

December 18, 2019

FDA sent a warning letter to Dercher Enterprises, Inc., DBA Gordon Laboratories, for CGMP violations and adulterated drug products.

EMA Launches Inspection Pilot Program

December 18, 2019

The European Medicines Agency and its European partners have launched a pilot program for cooperation in the inspection of facilities that manufacture sterile drug products.