Quality Systems

Articles

FDA sent a warning letter to Clientele for CGMP violations at the company’s Sunrise, FL facility that included a lack of an adequate quality unit.

Florida Company Receives FDA Warning Letter

Sunstar Americas is expanding its voluntary recall of Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12% products because of Burkholderia lata contamination.

Recall of Paroex Oral Rinse Expanded

The ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System is the first in a four-part series that will address refining pharmaceutical quality and guaranteeing sustainable compliance within organizations.

ISPE Releases First Guide from its Advancing Pharmaceutical Quality Program

Will Kanyi is Senior Training Specialist at Catalent Biologics.

Alternative approaches to training design can better address the desired performance outcomes in a GMP environment while delivering relevant information to meet regulatory compliance.

Compliance vs. Competency: Designing CGMP Training with Performance Outcomes in Mind

The Vaccines Manufacturing and Innovation Centre (VMIC) has chosen Lonza’s MODA-EM solution for the digitalization of its microbiology quality control operations.

VMIC Adopts Lonza’s Paperless Quality Control Microbiology Platform

The product is being recalled because of Burkholderia cepecia contamination.

Regenecare HA Hydrogel Recalled

The collaboration addresses the need for risk mitigation plans in cell therapies.

Cytiva and 4Tune Engineering Collaborate on Cell Therapy Quality Risk Management

Stephanie Snow is CMC manager at Kinapse Ltd, UK.

Niamh Panesar is CMC senior manager at Kinapse Ltd, UK.

Rakesh Suman is consultant at Kinapse Ltd, India.

Industry should improve the standards on application of risk management tools in light of the cases of nitrosamine impurities.

Nitrosamine Impurities in Medicinal Products

USP is preparing for 2021 while also supporting the development of vaccines and treatments for COVID-19.

USP, COVID-19, and Plans for the Future

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

Virtual audits, virtual training, and more robust quality agreements may become positive impacts on the industry, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.


Quality Assurance/Quality Control