From Regulators To PUPSIT: Notes On Annex 1 Revision Implementation

By Kevin Smyth, Director, Process Specialist, GST

The pharmaceutical industry is subject to some of the most rigorous regulatory requirements in the world. The good news for pharmaceutical manufacturing companies is that the regulators who developed Annex 1 are not innovators. They are merely reporters and codifiers. Nothing in this set of thinking involves original research or technology. Instead, they performed due diligence – outstanding due diligence, in fact – in reviewing the best current practices in the industry.

The European Union’s Good Manufacturing Practice (GMP) Annex 1 Revision will offer a broad-reaching regulatory revamp that will impact any pharmaceuticals manufactured for export to the EU. Kevin Smyth, a biochemical engineer with 30 years of experience in the pharmaceutical industry, offers insights and expertise in working with firms to understand what regulators seek to meet new standards.