Watlow Eurotherm® Technical Paper: Guide to regulations affecting EMS design

Life science customers of international thermal solutions leader Watlow® will benefit from the latest Technical Bulletin from its Eurotherm® division that provides a complete overview of all the leading worldwide regulations and guidelines that affect design and specifications of EMS Environmental Monitoring Systems.

The guide ‘Life Sciences Automated Environmental Monitoring Systems: Regulations and Guides’ is authored by Eurotherm Global Business Development Manager for Pharma, Roberto Zerbi, drawing on his 25 years’ experience, covering the entire pharmaceutical product life cycle.

Ready reference

The White Paper provides a ready reference starting point that identifies the principal rules and regulations that define the various aspects of environmental monitoring of a pharmaceutical facility that must be considered when specifying control systems and automated environmental monitoring solutions.

It offers a comprehensive rundown of the almost 50 separate pieces of North American and European regulations and their annexes, together with relevant international guidelines that define environmental monitoring standards. For each, it itemizes the various sections, chapters and headings that together define regulatory expectations for inspectors in North American and European markets.

Regulatory bodies covered include the US Food and Drug Administration (FDA), the EudraLex codes defining medicinal standards in the EU, and the harmonization standards and guides issued by the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Importance of EMS

The Guide prioritizes those regulations, guides, and inspection practices that impact most directly on environmental monitoring in the life science industries, where GMP compliance is determined by the product purity, safety, and quality of products, rather than the functionality of the EMS itself.

The length and complexity of even this prioritized list emphasizes the key role that EMS design plays in the life sciences, since there is almost no pharmaceutical or medical production process in which environmental parameters are not required to be monitored.