Quality Systems

Agnes Shanley is senior editor of Pharmaceutical Technology.

Articles

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.

Simple by Design

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.

MilliporeSigma and Solvias Partner on New Pyrogen Detection Kit

The new draft guidance addresses the premarketing assessment of a drug’s effect on blood pressure.

FDA Publishes Guidance on the Effects of Drugs on Blood Pressure

FDA sent a warning letter to Jilin Shulan Synthetic Pharmaceutical Co., Ltd. after an inspection found CGMP violations including a lack of data integrity.

Data Integrity Failures Found at China Facility

Representatives from the two pharmacopeias held a symposium on European and Indian legislation and regulatory requirements regarding the quality of drugs. 

European and Indian Pharmacopoeias Coordinate on Quality Standards

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.

Apotex Recalls Product Due to Elevated Levels of Impurities

The company is recalling Piperacillin and Tazobactam for injection, USP 3.375 g because of glass particulates found in a vial.

AuroMedics Pharma Issues Recall Due to Glass Particulates in Vials

Ed Trappler is president and founder of Lyophilization Technology, Inc. a contract research and technical services firm dedicated to freeze drying. He has over 40 years of experience in lyophilization that ranges from product development to equipment application engineering. He received his Bachelor of Science degree in chemistry at The College of New Jersey. His experience in the pharmaceutical industry includes product development, toxicology supply preparation, clinical manufacturing and parenteral production.

Amy M. Bosch is Scientist I at Lyophilization Technology, Inc. (LTI). As a Scientist I and Project Director, she is involved in managing client projects including product and process development, clinical and toxicological material preparation, technical support, and troubleshooting. Amy holds a B.S. degree from Millersville University in Biology. 

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.

Residual Moisture Testing Methods for Lyophilized Drug Products

Russell E. Madsen is the former senior vice-president of science and technology at PDA, and is a current member of Pharmaceutical Technology's editorial advisory board.

Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies.

Understanding Validation and Technical Transfer

FDA sent a warning letter to Goran Pharma Private Limited citing inadequate quality control violations.

Quality Assurance/Quality Control