Fortis Life Sciences
 

« Previous article
Long COVID-19 Study ...

29th August 2022  Product update: 

New EU GMP Annex 1 is Now Published - Find Products to Help Implement the Changes


Finally after the long consultation process, the new EU GMP Annex 1 (Manufacture of Sterile Medicinal Products) is now published with an implementation deadline of 25 August 2023. Download your copy of new EU GMP Annex 1 here - health.ec.europa.eu

And if you want to discover what has changed, this document from European Compliance Academy compares the exact text changes - www.gmp-compliance.org

Here below we have collated some products and services that will help you meet the new requirements.

GMP Annex 1: Changes in Microbial Monitoring - a rapidmicrobiology podcast

GMP Annex 1: Changes in Microbial Monitoring - a rapidmicrobiology podcast

In this episode, Anne Klees and Adele Gisselmann (Global Product Managers with Merck KGaA Darmstadt, Germany) unravel the New GMP Annex I (Draft 2020) and explain what effect its changes and new sections will have on environmental microbial monitoring.
Find Out More

 

Cherwell Supports PHSS Annual Conference 2022

Cherwell Supports PHSS Annual Conference 2022

With the publication of the new EU GMP Annex 1, delegates attending the PHSS Annual Conference will have an opportunity to ask Cherwell experts for practical advice and solutions on environmental monitoring and process validation for aseptic processing of Biological and ATMPs.
Find Out More

 

Contamination Control Strategies: What They Are and Why You Need Them

Contamination Control Strategies: What They Are and Why You Need Them

The recent draft of Annex 1 mentions contamination control strategies many times. It states that they should be in place across all sterile manufacturing sites. But what is a contamination control strategy and why are they important? Find out here.
Find Out More

 

Cherwell’s Accessory Product Portfolio Aids EU GMP Annex 1 Compliance

Cherwell’s Accessory Product Portfolio Aids EU GMP Annex 1 Compliance

Cherwell’s range of environmental monitoring accessories are designed to protect samples and support EU GMP Annex 1 compliance ensuring maximum protection of environmental monitoring samples, for manufacture of sterile medicinal products.
Find Out More

 

SAS Daily Heads Can Help Reduce Risk in Environmental Monitoring

SAS Daily Heads Can Help Reduce Risk in Environmental Monitoring

SAS Daily Heads are a viable way to help reduce risk and ensure compliance to the new stringent risk management and contamination control strategy within the revised EU GMP Annex 1. These certified sterile disposable air sampler heads provide an alternative to reduce the risk of false positives.
Find Out More

 

App Note: Effectiveness of Higher Volumes and Sequential Sampling in Active Air Monitoring

App Note: Effectiveness of Higher Volumes and Sequential Sampling in Active Air Monitoring

Results from a study investigating the potential microbial contamination risk to a product from manufacturing processes are available. Researchers modified the most frequently used active air sampling method in a non-controlled environment to enhance knowledge of risks involved. 
Find Out More

 

Addressing Challenges of Quality Control Labs in Vaccine Manufacturing

Addressing Challenges of Quality Control Labs in Vaccine Manufacturing

In cell culture-based vaccine manufacturing processes, microbial contamination control and impurity testing are crucial quality control components. Smart and rapid solutions streamline the daily routine and accelerate time to result.
Find Out More

 

Continuous Viable Air Monitoring Solutions to Meet EU GMP Annex 1

Continuous Viable Air Monitoring Solutions to Meet <br/>EU GMP Annex 1

The ImpactAir-ISO-90 and ImpactAir-90 ranges helps users address continuous monitoring challenges presented by the new Annex 1. The modular design provides differing formats to suit specific deployment needs and challenges within your facilities.
Find Out More

 

How to Handle Environmental Monitoring in Isolators - A rapidmicrobiology Podcast

How to Handle Environmental Monitoring in Isolators - A rapidmicrobiology Podcast

In this episode, Adele Gisselmann (Global Product Manager with Merck KGaA Darmstadt, Germany) describes the challenges of performing environmental monitoring in isolators, like manipulation with thick gloves and the effect of VHP, and explains how smart product design overcomes these challenges.
Find Out More

 

The Growth Promotion Test - How to Choose and Validate Your EM Culture Media Supplier

The Growth Promotion Test - How to Choose and Validate Your EM Culture Media Supplier

Peter Penn, Sales Director at NaughtonPenn Consultants discusses products that are designed to help laboratories ensure they achieve the correct CFU of reference organisms required to carry out the various testing procedures that they perform, whether it be the GPT or other tests.
Find Out More

 

How to Use the Data From Your Environmental Monitoring Program to Make Better Decisions

How to Use the Data From Your Environmental Monitoring Program to Make Better Decisions

Lonza’s MODA® Solution can overcome the challenges of paper-based data capture methods by offering comprehensive analysis, and trend reporting tools, including dashboards and heat maps, enabling companies to make decisions in real time.
Find Out More

Training, Webinars, Workshops for Annex 1 Compliance:

2022 PDA Annex 1 Workshop - 22/23 September in person, Amsterdam

A Guide to GMP Regulations – Recorded four-part mini series, free to access

Aseptic Process Simulation (APS) / Media Fills - 27/28 October, Live Online Training


    

Tags:


Date Published: 29th August 2022

Note: This content has been edited by a rapidmicrobiology staff writer for style and content.