Drug Development

Articles

Our GMP Agent-in-Place at a top-10 pharmaceutical manufacturing firm reports on a spill during the manufacture of a time-release capsule filled with coated beads.

But They're Not Touching the Floor...

Laura Bush is a former managing editor of Pharmaceutical Technology and Editor-in-Chief of BioPharm International.

In 1987, when the US Food and Drug Administration issued its Guideline on General Principles of Process Validation, a young FDA reviewer asked her supervisors.

The End of Process Validation As We Know It?

The question of pharmaceutical pricing is going to be resurrected by the European Commission, despite French President Jacques Chirac's rejection of the new EU treaty. Günther Verheugen, the Commission vice president, made this announcement at the annual meeting of the European Federation of Pharmaceutical Industries and Associates in Brussels (Belgium) responsible for competitiveness.

Regulatory Affairs

New maintenance models focused on efficiency improvements can deliver cost savings and enhanced service quality.

Considerations for Outsourcing Laboratory Equipment Maintenance

Reading the good automated manufacturing practice (GAMP 4) guide acquaints you with the now classic and almost famous V-model.1 The V-model, originally used for describing a validation workflow of IT and automated systems, is easy to understand and very good at ensuring that the requirements and design are built into the final solution. It is also extremely versatile and can be used for almost any type of validation task you could meet in a development phase.

Does 21 CFR Part 11 Provide Any Benefits?

FDA Pilots New Quality Assessment System

Able Interim Chief Resigns Amid Drug Recall

Police Lines

A stepwise, process risk-assessment approach can facilitate the identification and understanding of critical process parameters, quality attributes, and in-process controls. This approach can lead to more use of science- and risk-based regulatory practices to simplify the regulatory requirements for changes to synthetic processes and to support the underlying quality systems that ensure compliance.

Process and Scaling