Cherwell comments on EU GMP Annex 1 revisions


British lab will be offering expert knowledge on environmental monitoring and process validation at events in the UK and Ireland this month

Cherwell comments on EU GMP Annex 1 revisions

Cherwell Laboratories will be offering expert knowledge and demonstrating its range of specialist environmental monitoring and process validation products at two conferences in the UK and Ireland, to be held in May. These events will focus on the revision of EU GMP Annex 1.

At both events, Cherwell will advise visitors on how to improve environmental monitoring following the eventual publication of this significant amendment in guidelines for the manufacture of sterile medicinal products.

The first event is the Cleanroom Technology Conference (16-17 May), which will be held at the National Conference Centre in Birmingham (UK). The conference aims to help delegates keep up to date with cleanroom standards and ensure compliance.

The 2 day event will focus on best practice and regulations affecting both cleanroom design and cleanroom operation. Day 1 concentrates on regulations and standards and will start with a keynote presentation on the 2017 Draft revision Annex 1 of the EU GMP / ISO 14644. Day 2 focuses on cleanroom design and operation.

The second event, the Parenteral Drug Association Annex 1 – Revision of the EU GMP Guideline, will be held on 17 May the Crowne Plaza Dublin, in Blanchardstown, Ireland. The conference has been set up by PDA Europe to consider the impact of the proposed revisions to Annex 1 on both the industry and manufacturers.

The event will cover the intended amendments from a regulator’s perspective – covering important improvements and developments; as well as from an industry perspective – reporting on the comments submitted by the PDA task force to the EMA.

Representatives from Cherwell will be on hand at both events to discuss and highlight how its products for environmental monitoring applications can help to maintain future good manufacturing practice (GMP) inline with EU-GMP Annex 1.

The company will also demonstrate its product range and offere delegates practical advice and solutions tailored to customer specific requirements. The Cherwell range includes Redipor prepared media, stainless steel accessories and SAS microbial air samplers.

Andrew Barrow, Sales Manager at Cherwell Laboratories, said: “We are aiming to attend as many events as possible that are focusing on the revision on EU GMP Annex 1. As always, we like to attend these events to keep up to date with industry trends and regulatory changes, and we are particularly keen to listen to the industry’s reaction to the draft.”

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“We want to be available to discuss how we can help customers to maintain compliance once the revisions have been approved and published. Events like these are the ideal platform to enable us to do this,” Barrow concluded.