Quality Systems

Apr 11, 2018
By Pharmaceutical Technology Editors
FDA sent a warning letter to Tris Pharma Inc. after investigators found the company had failed to properly investigate batch failures and establish quality control procedures.
Apr 02, 2018
Pharmaceutical Technology
Taking vendor product data at face value puts pharmaceutical manufacturers and their supply chain partners at risk.
Mar 06, 2018
By Pharmaceutical Technology Editors
The company is recalling three lots of Hydromorphone HCl Injection USP CII 10 mg/mL, 1 mL in 2 mL Single Dose Vials because of possibly empty or cracked vials.
Mar 06, 2018
By Pharmaceutical Technology Editors
The company is recalling Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g manufactured by Gland Pharma Ltd and distributed by Sagent due to out-of-specification impurity results.
Mar 02, 2018
Pharmaceutical Technology
FDA enforcement efforts and drug approvals trend upward.
Feb 02, 2018
Pharmaceutical Technology
While more companies are embracing taggants, researchers are developing new technologies that will be extremely difficult to reproduce.
Feb 02, 2018
Pharmaceutical Technology
Hospitals form not-for-profit drug company to combat drug shortages and high prices.
Feb 02, 2018
By Pharmaceutical Technology Editors
The NECC supervisory pharmacist at the center of the 2012 fungal meningitis outbreak was sentenced to 8 years in prison.
Feb 01, 2018
Pharmaceutical Technology
Chemical engineers and chemists each bring unique skills to API process development and optimization. Success depends on their close collaboration, at both sponsor and CDMO facilities.
Jan 02, 2018
Pharmaceutical Technology
A new algorithm uses a statistical approach to critical process parameter assessment, allowing for faster, more consistent, and less subjective critical process parameter quantification, visualization, and documentation.
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