Quality Systems

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.

Articles

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general council, both of Regulatory Compliance Associates, discuss the requirements for a successful corrective action and preventive action (CAPA) system.

Defining Crucial CAPA Components

Mitigating risk in the bio/pharmaceutical sector demands a holistic approach.

Limiting Risk in Bio/Pharmaceutical Development

Hallie Forcinio is packing editor for Pharmaceutical Technology and Pharmaceutical Technology Europe, editorhal@sbcglobal.net.

Checkweighers, metal detectors, x-ray inspectors, leak detectors, headspace analyzers, and optical inspection systems for packaging were demonstrated at INTERPHEX 2015.

Quality Control Solutions at INTERPHEX: Inspection and Detection Systems

Sepha's VisionScan Max can leak-test full production batches of blister packs.

Nondestructive Leak Detection Equipment Minimizes Operator Input

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

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to handle internal audit reports during inspections.

Compliance with US and EU Internal Audit Requirements

James L. Brooks is a global quality control systems manager with Lonza Group Ltd.

Kurt In Albon is head of global IT quality Lonza Group Ltd.

Daniel Davis, PhD, is a global GMP compliance specialist with Lonza Group Ltd.

Heightened regulatory scrutiny of data integrity highlights the need for comprehensive procedural reviews and strategies for managing mission-critical information.

A Risk-Based Approach to Data Integrity

Agnes Shanley is senior editor of Pharmaceutical Technology.

An ISPE guidance document, four years in the making, brings risk-based thinking, statistics, and Lean Six Sigma to cleaning validation.

Getting Scientific About Cleaning Validation

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Presenters at IVT's Microbiology Week discussed best practices and recent guidance publications for microbial control in sterile and non-sterile pharmaceutical processes.

Microbiologists Contribute to a Quality Culture

Optical inspection equipment for packaging was displayed at INTERPHEX 2015.

Quality Control Solutions at INTERPHEX: Optical Inspection

The new Kaye Validator AVS combines accurate sensor measurements with all GMP requirements for calibration and traceability.

Quality Assurance/Quality Control