Nov 23, 2022

Microbiology & Bio contamination Control in Cleanrooms From EN ISO 14698 to a new EN 17141

Nov 7, 2022

Overview of GMP Annex 1 and its impact on Environmental Monitoring

Oct 26, 2022

GMP Annex 1 2022 Update Breakdown: Part 2

In 2017, GMP released a draft update to Annex 1, which received a lot of feedback. Now, GMP has released a finalized version of the updated Annex 1, which addresses many of the concerns and questions raised about the draft version. The largest changes and shifts in this document are found in the increased focus […]

GMP Annex
Oct 19, 2022

GMP Annex 1 2022 Update Breakdown: Part 1

The European Union (EU) Good Manufacturing Practice (GMP) for Medicinal Products for Human and Veterinary Use – Annex 1, commonly referred to as GMP Annex 1, was originally published as a draft in 2017. This draft left many people operating in the pharmaceutical industry wondering at some of the proposed changes to the regulations that […]

Jun 16, 2021

Let’s Prepare an ISO 14644-1 and GMP Annex 1 Cleanroom Classification Report Together

May 13, 2021

GMP Annex 1 2020 Draft: Effects on cleanroom classification and monitoring

Jan 22, 2021

GMP Annex1 2020 Draft and its Effect on Cleanroom Classification and Monitoring

Jul 7, 2020

Annex 1 2020 Draft and Cleanroom Monitoring

Jun 26, 2020

Annex 1 2020 Draft and Cleanroom Classification

Jan 24, 2020

An Introduction to EU GMP (European Union Good Manufacturing Practices) Annex 1 – Part 2 of 2

Jan 22, 2020

An Introduction to EU GMP ( European Union Good Manufacturing Practices) Part 1 of 2