Quality Systems

Articles

The agency is warning these manufacturers that they are putting consumers at risk with substandard manufacturing practices. 

FDA Sends Warning Letters to Manufacturers of Homeopathic Products

Leachable silicone oil may have an effect on large-molecule APIs, making it important to establish a robust analytical method to detect and quantify the substance.

A Study of Leachable Silicone Oil in Simulated Biopharmaceutical Formulations

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

Quality cannot be verified through testing, especially at the limit of detection, and no test method can confirm the absence of a microbe or particle.

Unknown and Unknowable

The new guidance was issued to assist applicants in determining which abbreviated pathway to take for submitting marketing applications.

FDA Guidance on ANDA and 505(b)(2) Applications

The new guidance document discusses reproductive toxicity testing and labeling recommendations. 

FDA Releases Oncology Drug Guidance

FDA sent a warning letter to Dong Yuan Technology Co., Ltd. detailing CGMP violations including failure to follow laboratory and process controls.

China Facility Receives FDA Warning Letter

The agency is updating its warning requirements for eszopiclone, zaleplon, and zolpidem after reports of complex sleep behaviors.

FDA Requiring Boxed Warning on Insomnia Drugs

The company is recalling one lot of Mycophenolate Mofetil for Injection, USP because of glass fragments found in a vial after reconstitution.

Par Pharmaceutical, Inc. Recalls Mycophenolate Mofetil for Injection, USP

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

A data exchange program between GE Healthcare and Amgen aims to improve biologics manufacturing through analysis of how raw materials affect the process.

Data Insights Improve Process Reliability

Ronald A. Rader is senior director, Technical Research, at BioPlan Associates.

FDA inspections can create uncertainty. Supervision of the contract manufacturer 
is crucial in ensuring compliance. 


Quality Assurance/Quality Control