CPhI Online

Why ISO 17034?

2 Oct 2020

As a provider of reference materials for a broad range of scientific industries, many of LGC Standards’ products are manufactured according to the International Organisation for Standardisation’s accreditation scheme for reference material providers, ISO 17034.

Unlike ISO 17025, which is concerned with the competence of testing and calibration laboratories in general, ISO 17034 is specifically designed to provide a regulatory framework for reference material producers (RMPs).

Published in 2016, the latest iteration of ISO 17034 introduced a number of updates and revisions to what was then a seven-year-old document (ISO guide 34:2009), bringing it into alignment with ISO’s ‘17000 series’ of conformity assessment schemes. These schemes – many of which are produced in partnership with the International Electrotechnical Commission (IEC) – cover a wide range of topics, from the application of braille on signage, equipment, and appliances (ISO 17049) to the technical specifications of meteorological weather balloons (ISO 17717).

In order to align the scheme with this wider conformity assessment series, a joint working group, formed by experts and stakeholders from the ISO Committee on Conformity Assessment (ISO/CASCO) and the ISO Committee on Reference Materials (ISO/REMCO), worked meticulously on the revision for two years. The committee updated the structure of the document according to a sequence employed across ISO’s conformity assessment standards, as well as specifying or elaborating on a number of requirements. 

Whilst it may not roll off the tongue, ISO 17034 is at the core of much of our work here at LGC Standards. The scheme provides a detailed breakdown of the general requirements for competence insofar as RMPs areconcerned , and as such is intended to be used in conjunction with general quality assurance procedures for the production of reference materials. Whether we’re producing high-end reference materials for laboratories in the pharmaceutical, food & beverage, or industrial sectors, our accreditation means we can reliably demonstrate the quality of our operations for the complete production process.

Navigating the intricacies of ISO accreditation can be dizzying, but the end result for laboratories sourcing ISO 17034-accredited reference materials is ultimately a step-up in both quality and international reputability. Insofar as LGC’s ISO 17034-accredited pharmaceutical reference materials are concerned, assay values are determined by an ISO 17025-accredited method, and verified by a secondary, independent technique. These materials are accompanied by a detailed certificate of analysis (CoA), alongside a measurement uncertainty. They are also tested for stability and homogeneity, further increasing their reliability.   
Just like any other scientific product, ISO 17034 reference standards are best thought of as a tool – a tool fit for a specific purpose. Over 550 of LGC’s range of pharmaceutical APIs are ISO 17034-accredited – for some laboratories, such as research laboratories, sourcing products of the highest possible quality is not essential, but for pharmaceutical laboratories these pharma-grade API reference standards represent the cream of the crop when it comes to reference standards.

“Customers producing a drug substance or drug product meant for human consumption would benefit most from the use of an ISO 17034 API reference standard,” says Sabrina Kusserow, global product manager for pharmaceuticals at LGC Standards. “In order to guarantee safety of the medicine, strict regulations need to be followed – it’s therefore necessary that our customers produce accurate analytical results, and are able to demonstrate this to the authorities.”

For instance, following a Marketing Authorisation Application (MAA), auditors may review used reference standards documentation. Should the used reference standards prove insufficiently characterised, or should the certificate of analysis be found lacking information, complications will be sure to arise. “Using a reference standard that was manufactured under ISO 17034 accreditation reduces the risk of false results, and also the risk of audit findings,” says Kusserow.