Quality Systems

Aug 17, 2017
By Pharmaceutical Technology Editors
The company is voluntarily recalling Lorazepam Oral Concentrate, USP 2mg/mL because of misprinted dosing droppers.
Aug 14, 2017
By Pharmaceutical Technology Editors
The agency sent a warning letter to Cellex-C International regarding GMP violations found at the company’s Toronto facility.
Aug 14, 2017
By Pharmaceutical Technology Editors
A pilot program will offer instruction on scientific and regulatory guidelines including training on GMPs and quality.
Aug 02, 2017
Pharmaceutical Technology
EMA recognizes the need to provide more assistance and guidance to SMEs developing new medicines and applying for marketing authorizations.
Aug 02, 2017
Pharmaceutical Technology
Lawrence Yu, Deputy Director, Office of Pharmaceutical Quality at FDA’s Center for Drug Evaluation and Research (CDER), shares insights with Pharmaceutical Technology.
Aug 02, 2017
Pharmaceutical Technology
FDA’s Emerging Technologies Team (ETT) team chair Sau Lee describes the reasons for the team and its structure.
Aug 02, 2017
Pharmaceutical Technology
Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.
Aug 02, 2017
Pharmaceutical Technology
Systems that discourage continuous improvement threaten pharma innovation, quality, and supply. Can the industry break through this deadlock?
Aug 01, 2017
Pharmaceutical Technology
Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
Jul 31, 2017
By Pharmaceutical Technology Editors
Stainless-steel particulates were found in one lot of 0.9% Sodium Chloride Injection, USP 1000 mL, prompting the recall to the hospital/user level.
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