Quality Assurance/Quality Control

Jun 04, 2018
By Pharmaceutical Technology Editors
The company is recalling two lots of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system due to particulate matter on the syringe plunger.
Jun 02, 2018
Pharmaceutical Technology
Dissolution testing remains one of the pharmaceutical industry’s most straightforward, least expensive QC tools. Research is focusing on ways to extend its reach, improve in-vitro and in-vivo correlation, and make real-time release testing a reality.
Jun 02, 2018
Pharmaceutical Technology
This paper analyzes the effectiveness of histogram binning for representing particle-sizing measurements with accuracy and precision.
Jun 01, 2018
Pharmaceutical Technology's In the Lab eNewsletter
By Pharmaceutical Technology Editors
The new kit is expected to detect a broad spectrum of pyrogens while offering high reproducibility and sensitivity as well as eliminating the need for live animal testing.
May 30, 2018
By Pharmaceutical Technology Editors
FDA sent a warning letter to Jilin Shulan Synthetic Pharmaceutical Co., Ltd. after an inspection found CGMP violations including a lack of data integrity.
May 30, 2018
By Pharmaceutical Technology Editors
The new draft guidance addresses the premarketing assessment of a drug’s effect on blood pressure.
May 17, 2018
By Pharmaceutical Technology Editors
Representatives from the two pharmacopeias held a symposium on European and Indian legislation and regulatory requirements regarding the quality of drugs.
May 16, 2018
By Pharmaceutical Technology Editors
The company is recalling Piperacillin and Tazobactam for injection, USP 3.375 g because of glass particulates found in a vial.
May 16, 2018
By Pharmaceutical Technology Editors
The company is recalling Piperacillin and Tazobactam for Injection, USP 3.375 Gram/Vial And 4.5 Gram/Vial strengths because of concerns of decreased potency due to elevated levels of impurities.
May 15, 2018
Pharmaceutical Technology
Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies.
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