Quality Control/Quality Assurance

FDA issued a warning letter to the company for quality control violations.

The agency sent a warning letter to Cape Apothecary for adulterated drugs.

FDA issued a warning letter to College Pharmacy for multiple violations.

The Chinese facility was cited for data integrity violations.

A $2-million, three-year grant will explore how statistically-based pharmaceutical quality standards might be established.

Xiamen Origin Biotech Co., Ltd, was cited, not only for inadequate quality management, but for falsifying information on certificates of analysis, having fictional employees sign CoAs, and having employees lie to inspectors.

Regulators and manufacturers address economic and ethical issues for scarce medicines.

The study demonstrates a systematic approach to stabilize PBS-formulated mAbs against freeze-thaw degradation.

The agency recommends suspending drugs developed with bioequivalence studies performed at Semler Research Centre Private Ltd, Bangalore, India.

FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.

The draft guidance addresses control of elemental impurities in harmonization with implementation of ICH Q3D guideline.

The issues cites the Taiwan facility with violations of current good manufacturing practice regulations.

FDA sent a warning letter to The Compounding Pharmacy of America for deficiencies in sterile manufacturing.

The agency cited a Memphis drug compounder for misbranded drugs and a lack of appropriate sterile processes.

FDA cited a Las Vegas compounding pharmacy for sterility violations.

The agency cited KO DA Pharmaceutical Co. with cGMP violations.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses training personnel on data integrity.

FDA and bio/pharma companies get serious about continuous manufacturing to ensure product quality.

FDA issues a warning letter to Megafine Pharma Limited for data integrity violations.

The agency cited Tai Heng Industry with CGMP deviations, including failure to ensure data integrity.

The agency cited Apotheca Supply, a repackager and relabeler of pharmaceuticals for CGMP violations.

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.

Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk mitigation.

The agency now allows production of water for injection by non-distillation technologies.

The agency cited Emcure Pharmaceuticals with CGMP violations.