Feb 22, 2024

Understanding the Essentials of EU GMP Annex 1 Section 9

Feb 22, 2024

EU GMP Annex 1 Merges with Pharma 4.0

Feb 7, 2024

The Future of Cleanroom Air Filtration: Advanced Systems for Enhanced Compliance

In the world of cleanrooms, where the highest standards of cleanliness and contamination control are paramount, air filtration systems play a pivotal role. The evolution of these systems, especially with the integration of advanced features, has significantly improved compliance with stringent industry standards. In this blog, we delve into the intricacies of these advanced air […]

Dec 19, 2023

EU GMP Annex 1 Continuous Viable Monitoring

Dec 13, 2023

EU GMP Annex 1:2022 and Microbial Monitoring for Viable Particulates

The 2022 update of the EU GMP Annex 1 has placed significant emphasis on the concept of continuous environmental monitoring (EM), highlighting it as a critical component in reducing the risk of contamination during the manufacture of sterile products.  This shift towards continuous EM requires manufacturers to adopt specific techniques and align their monitoring programs […]

Sep 13, 2023

The Vital Role of Contamination Control Strategy and Environmental Monitoring

In the complex landscape of pharmaceutical manufacturing, where the safety and efficacy of medicinal products are paramount, Annex 1 of the EU Guidelines for Good Manufacturing Practice (GMP) for Medicinal Products 2022 stands as a crucial document. One of its core components, the Contamination Control Strategy (CCS), plays a pivotal role in ensuring the production […]

Jun 8, 2023

OVERVIEW OF EU GMP ANNEX 1:2022

Mar 22, 2023

How To Develop and Document a Contamination Control Strategy

Your Contamination Control Strategy (CCS) is the foundation of your cleanroom. This is where you plan how to avoid contamination, what to do in the event there is a breach, and prove that you have done your homework.  For too many years, a CCS has been an afterthought. The cleanroom was developed, protocols put in […]

Mar 8, 2023

Risk Management and GMP Annex 1: Strategies for Minimizing Contamination

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, released a new update in 2022. At the time of publishing, we have not yet seen updates in the United States, but should expect to see similar guidelines published […]

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