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July 02, 2015
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to handle internal audit reports during inspections.
Heightened regulatory scrutiny of data integrity highlights the need for comprehensive procedural reviews and strategies for managing mission-critical information.
July 01, 2015
An ISPE guidance document, four years in the making, brings risk-based thinking, statistics, and Lean Six Sigma to cleaning validation.
June 17, 2015
Presenters at IVT's Microbiology Week discussed best practices and recent guidance publications for microbial control in sterile and non-sterile pharmaceutical processes.
May 20, 2015
Optical inspection equipment for packaging was displayed at INTERPHEX 2015.
May 12, 2015
The new Kaye Validator AVS combines accurate sensor measurements with all GMP requirements for calibration and traceability.
May 11, 2015
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.
May 02, 2015
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to keep up with changing regulations.
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.
April 14, 2015
The European Medicines Agency releases guidelines for addressing and reporting risks associated with medication errors.