Quality Systems

Richard J. Forsyth is principal consultant with Forsyth Pharmaceutical Consulting, 907 Shamrock Ct, Royersford, PA 19468, tel. 484.535.1688, forsythpharmaconsulting@gmail.com.

Articles

Visible residue limits have been shown to be a valuable tool in validated cleaning validation program.

Ruggedness of Visible Residue Limits for Cleaning Validation

Andrew Harrison is chief regulatory affairs officer and general counsel with Regulatory Compliance Associates.

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

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss how to create a robust CAPA system and how to identify root cause.

Creating Robust CAPA Systems

Agnes Shanley is senior editor of Pharmaceutical Technology.

Transparent communications, both qualitative and quantitative data, and a clear understanding of each other’s needs are keys to collaborating on better product quality.

Quality Metrics and Best Practices for Working with Contract Labs

Lab Services: To Outsource or Not to Outsource

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to streamline the document management process during market expansion.

Managing Market Expansion’s Effect on Procedures

Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.

While stakeholders generally welcome improvements to quality initiatives, they are concerned with how the new requirements will be implemented for more complicated supply-chain models.

Overwhelming Response from Industry on FDA’s Guidance on Quality Metrics

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to assure compliance for automated systems.

Computerized Systems Validation

FDA’s proposed guidance for quality metrics raises questions about quantifying the tangibles and intangibles of quality culture.

The Metrics of Quality Culture

Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

QbD is improving the safety of solid-dosage drug products as well improving manufacturing processes, despite some industry reluctance.

Quality by Design in Solid-Dosage Manufacturing

To enable efficient monitoring systems, life-science companies need to effectively apply run rules.

Quality Assurance/Quality Control