Quality Systems

Articles

The agency sent a warning letter to Cao Medical Equipment Co., Ltd. after inspectors found CGMP violations at the company’s Langfang, Hebei facility.

FDA Puts Chinese Manufacturer on Import Alert

Asclemed USA Inc., dba Enovachem Pharmaceuticals is recalling the product due to labeling that incorrectly states that stoppers do not contain latex. 

Dyural-40 and 61 lots of Dyural-80 Recalled

FDA has withdrawn the proposed rule that would have allowed generic-drug makers to independently update and distribute new safety information in drug labels.

FDA Looks to Modernize Generic Drug Labels

New FDA guidance developed to identify lapses in data integrity and promote best practices.

FDA Answers Data Integrity Questions

FDA cites Zhejiang Huahai Pharmaceutical in valsartan impurity investigation.

FDA Hits Valsartan Manufacturer with Warning Letter

Peter Zipfell is product marketing specialist, CMD Software, Thermo Fisher Scientific.

Integration of two separate chromatography data systems boosts workflow efficiency.

The Benefits of an Advanced Chromatography Data System

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

A required time frame should not be the driving force behind root cause investigations, says Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates.

Investigation Timeliness vs. Thoroughness: Finding the Right Balance

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Microbial identity data can be critical for determining contamination sources.

Microbial Identification Strategies for Bioburden Control

Agnes Shanley is senior editor of Pharmaceutical Technology.

Success depends on supplier communication and transparency, but it’s up to buyers to demand the right information and to look at the vendor’s overall business goals.

Going Beyond the Surface to Ensure Supplier Quality

Kent Malmros is senior director of training at Veeva Systems. He has spent the majority of his career delivering technology-enabled training solutions to life-sciences companies and has held leadership positions at companies that include AdMed, ClearPoint (Red Nucleus), and UL EduNeering (UL).

Simplified role-based training can lead to better quality metrics and compliance.

Quality Assurance/Quality Control