- Why should I buy from LGC Standards?
- Why are LGC Standards launching their own product range?
- Are you making these materials yourself or through a third party?
- Why should I buy LoGiCal® by LGC Standards?
- What quality accreditation does LGC Standards hold?
- What is ISO Guide 34?
- Are all third party suppliers of starting/raw material ISO Guide 34 accredited?
- Are LoGiCal by LGC Standards traceable back to System Internationalé (SI)?
- Why is traceability to the SI important?
- How does LGC Standards prove the identity and purity of their compounds?
- What is the chemical purity and where can I find them?
- Do we know the stability of the compounds?
- Are the accelerated stability studies performed before releasing a material into stock or concurrent with the release of the material or sale?
- Are there any special considerations in handling reference material solutions when removing from storage?,/
- Do all reference materials purchased need to be sourced from an accredited producer?
- Do I need two sources of ISO Guide 34 material to satisfy accreditation requirements?
- What are the 4 C’s and a Q?
- Will I still be able to buy my usual standards from LGC Standards?
- Will the expiry date be comparable to my current standards?
- Can my existing standards be directly substituted with LoGiCal standards?
- Will I need to re-validate my methods?
- What is the standard delivery time for LoGiCal standards?
- Will my standards arrive quicker if I buy LoGiCal by LGC Standards?
- Will my standards be cheaper if I buy LoGiCal by LGC Standards?
- Will I be able to obtain a free/discounted trial LoGiCal standard?
- Why can’t I buy products via the LoGiCal website?
- Do the vials and ampoules contain exactly 10 mg or 1ml?
- What do I do if I have more questions?
LGC Standards is Europe’s most comprehensive source of reference materials from the world’s leading producers. In addition to expertise and quality products in the area of clinical and forensics, LGC Standards product range also covers food, environmental, industrial, pharmaceutical and biological life science, giving rise to a large pool of knowledge across many sectors. Our many years’ experience in reference materials and associated analysis enables us to provide high levels of customer service and technical support. This experience, in combination with the network of European offices and relationships with key reference materials suppliers allows us to provide customers with simplified ordering, short delivery times and local support on the differing requirements for the importation of controlled and uncontrolled reference materials.
The production of reference materials is nothing new for LGC. We have been producing reference materials as part of our National Measurement Institute function for many years.
The LoGiCal products have been created to meet increased customer demand and regulatory requirements for ISO Guide 34 reference materials. In particular, accreditation bodies are increasingly interested in the use of independently sourced calibrator and controls. We are delighted to be able to offer our customers increased choice through this expansion of our product portfolio.
All reference materials branded LoGiCal are made in LGC’s own ISO 17025/IEC, ISO Guide 34, 9001:2008, and GLP/GMP accredited laboratories in Luckenwalde, Germany. The Luckenwalde facility is staffed by more than 80 analytical and synthetic chemists and support staff. This laboratory has been producing reference materials aimed primarily at the pharmaceutical industry for many years and through careful planning and significant investment, they have delivered this new portfolio of products. Their unrivalled experience in reference material production has allowed us to bring the highest quality processes to the production of a new generation of reference materials, suitable for modern analytical instrumental techniques.
Quite simply, LoGiCal reference materials were designed and manufactured to fully meet the needs of modern analytical laboratories. From clear and concise CLP labelling, to in depth and comprehensive certificates of analysis, from easy to open vials to language specific Safety Data sheets, the whole package was put together to make it as easy as possible for laboratory users.
- Are manufactured in house to the highest quality standards.
- Are produced and certified to ISO Guide 34 using ISO 17025 accredited processes.
- Have direct metrological traceability to the SI.
- Are the only solutions to be accompanied by data concerning the uncertainty of measurement when solutions are made or used at different temperatures.
- Undergo accelerated and real time stability testing.
- Have the most comprehensive certificates of analysis available.
- Have the majority of Material Safety Data Sheets available in local language.
- Fully satisfy national and international labelling for transportation and health and safety.
- Are available in powders and solutions at relevant quantities and concentrations.
- Make a number of substances available as powder and reference materials for the first time.
- Are competitively priced.
- Are stored locally at LGC Standards offices to minimise delays due to the complex, lengthy import procedures associated with the procurement of controlled substances.
Our operations are certified to ISO 9001. Our testing laboratory holds the ISO/IEC 17025 accreditation and our reference material production for the MMCRM and LGCAMP product lines is accredited to ISO Guide 34. We anticipate the LGCFOR product range also falling under the ISO Guide 34 accreditation by November 2012. Additionally we also hold a confirmation that we follow c-GMP as regards development and production of chemical reference substances.
ISO Guide 34:2000 outlines the general requirements for the competence of reference material producers. This guide is used as basis for accreditation of the producers. A copy of the ISO Guide can be purchased from your national standardisation body.
It does not matter that the original supplier of the material is ISO guide 34 accredited. ISO Guide 34 defines the requirements for establishing processes to bring a chemical to be a formal reference material.
As part of our ISO Guide 34 Certification there is a strict clearly defined and documented process to verify all materials that could potentially become reference materials. This overrides the requirements for the original supplier of the material to be ISO Guide 34 Certified.
Yes - LoGiCal solutions are ISO Guide 34 and have associated uncertainties and traceabilities obtained using valid reference measurement procedures, including elemental analysis (CHN) and quantitative NMR.
The système internationale (SI) is recognised the world over as the ultimate authority in terms of all types of measurements. Traceability directly back to the SI gives laboratories the confidence that the materials produced are as described in the certificate of analysis in terms of concentration and identity. Other definitions have been used to define the traceability of reference materials. These alternative definitions are less robust than direct traceability to the SI.
We have a number of highly trained and experienced chemists who have considerable expertise in the interpretation of analytical data. We use 1H-NMR, Mass Spectrometry, IR spectroscopy and HPLC-DAD for identification. In addition we use absolute methods including CHN analysis and/or quantitative NMR to support our interpretation. Where other physical properties are known then we also use this as an identity check (e.g. melting point, appearance, and polarimetry). Examples of our certificates of analysis can be found on the LoGiCal website. Alongside the data from the techniques specified above, these include a purity test by HPLC and evaluation of water content and residual solvent.
The chemical purity is an assessment of the presence/absence of contaminants in the neat material used to prepare the reference material. The purity is assessed using a number of methods, as described above. The concentration of the material in solution, and the associated uncertainty, take account of the purity of the neat material. No further corrections are required.
Purity information can be found on the certificate of analysis (Section II for powders/LGCFOR and section Section III for solutions/LGCAMP).
Our laboratory has a long history in producing active pharmaceutical ingredients (API) and pharmaceutical impurities for the pharma industry. We therefore have significant background information on the stability of many of the neat substances in the LoGiCal range. This information is used to specify validity period and storage conditions. However, the LoGiCal range includes a number of substances available as powder and/or solution reference materials for the first time. For these there is normally very little information available on stability, other than the predictions made by top quality chemists. For all our solutions and substances that are completely new to us, we run accelerated stability studies (55°C, 60% relative humidity for 24 and 48 hours) to get a first impression of their stability behaviour. These are backed up with additional stability testing at regular time points after first production. From the data obtained during these investigations, we make recommendations for the long-term storage of our reference materials. Additionally the quality of every lot is regularly investigated due to a quality control testing program, where strange results can lead to changes in the storage temperature.
Our normal practice is to complete the accelerated studies prior to product release. Occasionally to meet customer demands, we carry out concurrent studies, but these products are monitored carefully for any significant changes.
Instructions for handling reference materials can be found in section V. ‘Further Information’ of the certificate of analysis. Whilst some instructions for use are applicable to the handling of all reference materials occasionally some materials call for particular attention. For example, solutions containing substances with poor solubility may crystallize upon cooling and require additional care to ensure that they are fully dissolved prior to use. Gently warming to room temperature, sonication or additional mixing steps may be required. Always consult the certificate of analysis for instructions on use.
In general, accreditation bodies require the use of ISO Guide 34 reference materials if they are available. Laboratories must have confidence in the competence of the producer(s) from whom they obtain their reference materials. The basis of this confidence should be demonstrable to regulatory authorities and ISO Guide 34 accreditation is considered appropriate for this.
Do I need two sources of ISO Guide 34 material to satisfy accreditation requirements?
One source of ISO Guide 34 reference material may be sufficient for a laboratory’s needs. The use of two independent sources produced in accordance with ISO Guide 34 provides an additional level of confidence that the two will agree. The cost of consumables, analyst and instrument time required to repeat failed assays significantly exceeds the cost of using two independent ISO Guide 34 reference materials.
Many of the staff who have helped develop the LoGiCal range of materials have either worked in or managed analytical laboratories. We looked at their experiences and asked them what they would want in the logical product range. They came up with the 4 C’s and a Q.
So our commitment to you is based around:
- Quality: Produced under ISO Guide 34 and ISO 17025/IEC guidelines to satisfy your accreditation and certification requirements.
- Commitment: In-house forensic, clinical and analytical experts in combination with in-country representatives to support your use of these reference materials.
- Compliance: Fully satisfy national and international labelling and other requirements for transportation and health and safety.
- Competence: Expertise based on over 30 years of reference material production and over 70 years of forensic and clinical experience to support your current requirements and anticipate your future needs.
- Choice: A broad and continually developing product range to ensure you can obtain the reference materials you require.
Yes. LGC Standards has no intention on stopping selling other suppliers standards. The addition of LoGiCal standards to our portfolio puts us in the privileged position of being able to supply two independent sources of ISO Guide 34 reference materials. One for preparation of calibration materials, and the other for preparation of control materials.
The typical expiry assigned for our products is 2 years from the date of ampoulation. However, expiry dates are product dependant and based on accelerated and real time stability testing. As the new LoGiCal range includes a number of drugs that are offered in solution for the very first time, limited long-term stability data is available at this stage. The expiry dates are under continual review and will be amended as appropriate.
LoGiCal solutions are fully ISO Guide 34 certified and ISO/IEC 17025 compliant, which means laboratories can have confidence in the quality of the product, and the accuracy of the assigned values. However, users may wish to satisfy themselves that that the material is fit for purpose. The way in which this is done will vary from laboratory to laboratory, depending on whether or not protocols are in place for such scenarios. Either way, a full method revalidation is unnecessary. Preparing some calibrator or control material from the LoGiCal solution and analysing alongside existing calibration and control material should suffice. Providing LoGiCal is compared with a reference material of equivalent certification the there should be good agreement.
See ‘Can my existing standards be directly substituted with LoGiCal standards?’
The standard delivery time will be dependant on a number of factors, including the product you are ordering, whether it is controlled, whether the necessary licences are in place, where you are located, whether the product is in stock and so on. These questions are best answered on a case by case basis by discussing with your local office or sales representative.
All orders are delivered as soon as practically possible. Most delays in delivery are attributed to the requirement for import and export licences, which can be time consuming to obtain. This can lead to minor delays outside of LGC Standards control. As LoGiCal are produced by LGC we are able to maintain stores locally at our sales offices. This significantly minimises delays associated with import/export licences and enables us to dispatch materials much more rapidly. We also maintain local stores of ‘best sellers’ for some of our other suppliers.
LoGiCal standards are competitively priced with comparable products from other suppliers.
- Contact your local office or representative for your sales price.
- Additional discounts are negotiable for bulk purchases.
- Sales promotions will be offered periodically.
During the introductory phase of LoGiCal, a limited number of products will be made available for trial. Please discuss your individual requirements with your local office or sales representative.
Many of the materials we supply are controlled differently in different countries. To ensure that neither you nor LGC Standards breaches any regulatory requirements, the LoGiCal web site has been designed to allow you to put items into a shopping basket and request a quote. We will then respond appropriately, including details of any regulatory restrictions.
Sufficient material has been added to each product to ensure that end users will be able to dispense 1 millilitre or the weight detailed in the vial. It is best practice to dispense a defined amount from the product rather than assume that it contains exactly what is stated on the label in terms of weight or volume.
Please contact your local sales office or email email@example.com where we will answer your queries where ever possible.