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Revised EudraLex and Annex 1 GMP guidelines increase demand for Watlow Eurotherm® Compliance Solutions
St. Louis, Missouri, USA: – World-leading Industrial heating solutions provider Watlow™ is now able to offer industry-leading GMP compliance solutions and consulting through its recently acquired Eurotherm® subsidiary.
Demand for Eurotherm’s world-class process control, recording and automation solutions and expertise has become particularly pressing in view of imminent changes to the EudraLex Annex 1 and ISPE GAMP 5 guidelines governing GxP manufacturing in life science industries.
Eurotherm has created its suite of Life Sciences Digital Engineered Solutions to ensure processes that are safe, efficient, and sustainable, to comply with regulations and Quality by Design (QbD) principles.
EudraLex Annex 1 GMP guidelines updated
Annex 1 of the EudraLex, Volume 4, Good Manufacturing Practice (GMP) guidelines for medicinal products for human and veterinary use provides guidance for the manufacture of sterile medicinal products. Revised guidelines that come into effect from August 2023 are designed to keep pace with innovations in regulatory and manufacturing environments, science and technology and will affect sterile drugs made in the European Union, as well as imported products. Since US manufacturers need to comply with Annex 1 to sell into EU markets, the US FDA and other agencies, are adopting matching guidance.
The revised guidelines Incorporate quality risk management (QRM) principles into sterile drug manufacturing in line with International Council for Harmonisation (ICH) Q9 and Q10 technical requirements for Pharmaceuticals for Human Use. They also ramp up requirements for manufacturers of medicinal products to use modern production systems, introduce specific requirements for single use systems (SUS), and harmonize sterile drug manufacturing principles with World Health Organization (WHO) and Pharmaceutical Inspection Cooperation Scheme (PIC/S) standards.
ISPE GAMP® 5 revisions
The International Society for Pharmaceutical Engineering (ISPE) Good Automated Manufacturing Practice (GAMP®) guidelines were first developed in 2008 to address evolving FDA and other regulatory agency expectations that suppliers and users in the Life sciences industries will use systems based on prospective validation following a life cycle model. The GAMP® guidelines are recognized and utilized globally by many regulated companies and their suppliers as the ‘go to’ guide on computerized systems that are GxP compliant.
The GAMP second edition is intended to keep IT, software engineering and automation good practices up to date with latest available technologies, services and risk-based approaches with key changes that recognize the need for software development in large or custom systems to allow for iterative, incremental and exploratory methods, promoting an ‘agile model’ as an alternative to traditional linear waterfall methodology.
The revised guidelines highlight the importance of critical thinking, along with Case for Quality principles, to enable efficient risk-based assurance of software throughout the product lifecycle.
In particular, the development appendices update user requirement, functional and design specifications to allow for agile software approaches, while the Electronic Production Records (EPR) appendix now reflects cloud-based technology and blockchain, redefining expectations for electronic records, electronic signatures and audit trails. Operational appendices now reflect the modern Quality Management System (QMS) IT Infrastructure Library (ITIL) approach to software development, as well as updates on topics such as incident and problem management and operational change and configuration management.
The revised guidelines also address transition of traditional documents such as installation, operational and performance qualifications (IQs, OQs and PQs) to risk-based records with appropriate tools for modern software development lifecycles, Distributed Ledger Systems (blockchain) that allow use of distributed ledger technology (DLT), and recognise increased use of Artificial Intelligence and Machine Learning (AI/ML) and how these are applied in GAMP®.
In short, the ISPE GAMP® 5 Second Edition suggests a risk-based approach to compliant GxP computerized systems to support the life sciences industries’ transition from computerized system validation (CSV) to computerized system assurance (CSA).
How Eurotherm helps compliance with the revised requirements
Several new requirements and recommendations are included in the updated version of Annex 1, and they can represent compliance challenges for many sterile drugs manufacturers. To support life science companies’ compliance with the revised Annex 1 document, Eurotherm focuses priority on the following topics:
- Environmental Monitoring Systems: Eurotherm EMS Digital Engineered Solutions can monitor temperature, humidity, pressure, particle counters, and contamination according to the new guidance. Its EMS DES offerings leverage strategic partnerships to deliver pioneering solutions.
- Indicator of air pressure differences: To meet the Annex 1 requirements that air pressure differences should be continuously monitored and recorded, Eurotherm Store and Forward technology can be embedded in manufacturing systems to reduce the risk of data loss, avoiding gaps in the historic database and support the Data Integrity ALCOA+ principles. Alerts and alarms can be delivered to on-premise or cloud-based repositories and mobile devices.
- Heat sterilization: As a leading global supplier of data management technology, Eurotherm offers a solution to help OEMs and end users to meet point 8.50 of Annex 1, by providing off-the-shelf monitoring solutions and redundant control solutions that are cost-effective, easy to qualify and sustain good manufacturing processes.
To aid compliance with ISPE GAMP® 5 second edition, Eurotherm recognizes the transformation to modernized risk-based approaches and has adapted its project development, tools, templates, procedures and services to in line with the more agile model laid out in the revised GAMP® 5 document.
This GAMP® 5 engineering approach is already helping life science customers to simplify compliance, using project design, construction and engineering support services that align with the GAMP® 5 good engineering methodology, as well as ISPE GAMP® 5 document templates and products with built-in functions to help meet Category 3 and Category 4 requirements.
This is part of a suite digital engineered solutions and services that Eurotherm has developed to aid GxP compliance in life science applications. These include:
- High-integrity data management solutions (including cloud-based), with tamper-resistant digital data recording, archiving and reporting technologies, designed to help meet the GxP data lifecycle requirements in line with FDA 21 CFR Part 11, EudraLex Volume 4 Annex 11, and ALCOA+ data integrity principles
- Industrial automation products and services that aid cybersecurity robustness, helping to protect production processes and data from being compromised by cyber-attacks as part of a defense-in-depth strategy.
Watlow is a global industrial technology company that uses its world-class engineering expertise, advanced thermal systems and manufacturing excellence to enrich everyday life.
Many of the world’s leading companies leverage Watlow’s technologies in vital applications such as semiconductor processing, environmentally-friendly energy solutions and lifesaving medical and clinical equipment, to name a few.
Founded in 1922, Watlow’s culture is driven by its mission of “Enriching Lives Through Inspired Innovation,” enabling the company to deliver high-impact solutions that improve its customers’ competitive advantage.
Learn more at: https://www.watlow.com
Based in West Sussex, England, Eurotherm was founded in 1965, making temperature controllers from a flat above shops in Worthing, and has expanded over 57 years to become one of Europe’s most respected supplier of world-class process control, recording and automation solutions.
As Eurotherm International, the company has remained true to its founding vision to be the preferred supplier of machine automation products, applications, systems and services for customers in specialist industries, with a core mission to act as ‘trusted advisors’ with specialist knowledge and experience to achieve process excellence through machine automation efficiency and regulatory compliance.
Eurotherm offers a wide range of feature-rich products and software for industrial automation that is designed for easy operation and reduced engineering time, incorporating industry-leading control algorithms, recording and data management strategies that add value to manufacturing processes, improving quality, reducing waste and ensuring data security.
In late 2022, Eurotherm became a member of the Watlow group of companies providing world class engineering expertise and innovative thermal products and systems to numerous industries across the Americas, Europe and Asia.
Learn more at: https://www.eurotherm.com/