Quality Assurance/Quality Control

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.
May 15, 2018
Pharmaceutical Technology
Understanding the advantages and suitability of different methods to measure residual moisture content in lyophilized materials--and the respective limitations--aids in selecting the most appropriate method for testing.
May 14, 2018
By Pharmaceutical Technology Editors
FDA sent a warning letter to Goran Pharma Private Limited citing inadequate quality control violations.
May 02, 2018
Pharmaceutical Technology
The approach presented in this study uses process capability index results to establish sampling strategies for use with new product cleaning and to efficiently reduce the risk of insufficient cleaning.
May 02, 2018
Pharmaceutical Technology
The working acceptance limits for acceptance values (AV) are determined using the critical values at, for example, 95% coverage over the corresponding AV distributions. However, validity of such limits needs to be elaborated.
May 02, 2018
Pharmaceutical Technology
Airflow visualization studies, or smoke studies, confirm unidirectional airflow patterns in an aseptic processing facility.
Apr 30, 2018
By Pharmaceutical Technology Editors
FDA sent a warning letter to Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. for failure to follow current good manufacturing practices.
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