Quality Systems

Articles

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

Amphenol Introduces New Advanced Validation System

The basic principle behind QbD is that quality should be built into a product with an understanding of the product and process by which it is developed and manufactured along with a knowledge of the risks involved in manufacturing the product and how best to mitigate those risks.

QbD and PAT: A Marriage Made in Heaven?

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

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to keep up with changing regulations.

How to Stay Abreast of Shifting Regulations and Remain Compliant

Stephen Wicks, PhD, is the scientific regulatory policy and intelligence officer of the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe, Stephen.WICKS@edqm.eu. EDQM is a leading organization that protects public health and amongst other things is responsible for the European Pharmacopoeia.

The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users.

Ensuring the Quality of Biologicals

The European Medicines Agency releases guidelines for addressing and reporting risks associated with medication errors.

EMA Releases Medication Error Guidelines

FDA issues a Warning Letter to Hospira S.p.A. for GMP violations at the company’s Liscate, Italy facility.

Hospira Italy Facility Gets Warning Letter

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

The Human Microbiome Project has increased our understanding of the relationship between humans and microorganisms. The authors offer a new perspective on how this knowledge should be considered in setting standards for pharmaceutical quality control in microbiology.

The Human Microbiome Project and Pharmaceutical Quality Control Microbiology

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

A new machine is designed for inspection of prefilled syringes.

Automated Syringe Handling Helps Manual Inspectors

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses good engineering practices.

Managing Supplier Data Collection

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to handle staff challenges to regulation requirements

Quality Assurance/Quality Control