UKAS reference materials manufacturer
kromega Certified- Qualification Standards
The kromega range of Qualification Standards for HPLC and UV Spectrophotometers is designed to provide you with a solid foundation for your HPLC and UV Spectrophotometer instrumentation qualification.

Background

Since 1987, Jaytee have been a service provider for the UK’s HPLC & GC market. By the mid 1990’s, Jaytee’s customer base grew to include multi-national companies in a range of sectors, including pharmaceutical, agrochemical, fine chemicals, as well as many smaller contract laboratories. As a result, Jaytee became responsible for fulfilling qualification activities on behalf of our customers.

Over the last 15 years we have expanded our scope of services, moving from purely performing a customer’s method, through to designing our own. We now consult on instrument qualification for some of the world’s largest pharmaceutical companies.

This latest evolution has seen us successfully adapt to tighter regulations, using improved procedures for calibration / qualification. It is this insight that has led Jaytee to seek UKAS accreditation for a range of Qualification Standards which we are pleased to offer as Certified Qualification Standards.

Selling points – Foundation, Certainty, Global, Integrity, Cost Effective, Traceable, Confidence

  • By using Jaytee’s kromega Certified Qualification Standards, you can ensure that your calibration / validation activities are built on a solid foundation.
  • By using our standards, which have certified property values, the only variable in the qualification process will be the instrument.
  • Our standards have been developed for use in any laboratory, regardless of the regulator, and are as relevant to a pharmaceutical company as to a contract lab working to ISO 17025.
  • The standards come shipped in flame-sealed ampoules that are individually seated in custom made boxes in order to increase the shelf life, and to prevent contamination.
  • The relative cost for your organisation against developing a bespoke solution is minimal. For companies complying to any form of GxP regulation, there is a stated need to qualify equipment that generates data. This “out of the box” solution meets that requirement.
  • kromega CRMs are an easy, cost-effective means of achieving conformance, since all regulators require that qualification is traceable.
  • Traceable instrument qualification adds confidence to all data generated. In addition, your audit trail is backed up by the independent verification by UKAS to ISO Guide 34.

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UKAS reference materials manufacturerUKAS Qualification Standards

Why Develop The Range?

Jaytee have been involved in the qualification of analytical equipment for over 15 years and during that time we have seen the requirements for the traceability of calibration / qualification increase.
Regulators now require that all instruments be traceable to international standards. This is relatively straight forward for measurement of temperature or volume, however when the property involved is more difficult to define, for example measuring the wavelength accuracy on a HPLC UV detector, then Certified Qualification Standards (calibration) must be used.

How Did We Do It?

Over the last 4 years Jaytee have successfully undertaken a major project to become an “Accredited Reference Material Producer“, working strictly to the guidelines defined by the ISO Reference Materials Committee (REMCO), during which time we have relocated to a purpose built facility. The project was brought to a conclusion in October 2010 when Jaytee became Accredited to ISO Guide 34 by UKAS.

Who Is It Designed For?

The new range of CRMs benefit any company, operating anywhere in the world, who use analytical equipment to produce data for regulators.
In addition, service providers performing calibration / qualification on behalf of organisations will also benefit from the traceability that this product range offers.

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UKAS reference materials manufacturer
Our standards have been developed to be used in any laboratory regardless of the regulator and are as relevant to a pharmaceutical company as to a contract lab working to ISO 17025.
All products come supplied in flame-sealed ampoules to increase the shelf life and prevent contamination, with full certification available as pdf download.

Who / What Are The Regulations?

Organisations working within regulated environments such as Pharmaceuticals (FDA/ USP) and Agrochemicals (EPA) are required to provide documented evidence of the calibration/ qualification status of an instrument.
Any laboratory using analytical equipment must ensure that their instruments are operating correctly if they are to produce sound analytical results.

What Is ISO Guide 34?

ISO Guide 34 is an international standard which defines the requirements which must be adhered to in order to become an accredited reference material producer.
As an organisation accredited to ISO Guide 34, Jaytee Biosciences are inspected annually in order to ensure that we are meeting the requirements of the standard and retain our accreditedation.

Who Are UKAS?

UKAS are the United Kingdom Accreditation Service, which is the UK’s independent body responsible for the accreditation of organisations to a huge scope of national and international standards.
UKAS is the UK equivalent to A2LA in the USA, DAkkS in Germany and JAB in Japan along with many other national bodies throughout the world. As such, UKAS work to the international agreement for Certification Bodies, thus Jaytee’s certification carries a global stamp of approval.

CRM & The Data Quality Triangle

kromega CRM Data Quality TriangleUSP <1058> details the hierachy of Data Quality and works on the theory that “confidence in a higher level relies on completion of lower levels”.

Jaytee’s kromega products underpin the lowest layer of the triangle and therefore underpin all of your data.

Because of our Accreditation to ISO Guide 34, you can rest assured that our standards provide the vital traceable link to internationally observed standards, without which all qualification is regarded as suspect, thus undermining your data.

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Material Safety Data Sheets (MSDS)

The Material Safety Data Sheets (MSDS) for relevant CRM products are available as a downloadable pdf.

Please visit www.kromega.net/crm.