NLG Analytical has launched its v-kit analytical validation kits, allowing users to perform dependable OQ/PQ tests on their own analytical equipment
NLG Analytical says its new v-kits dramatically cut the cost of compliance - in some cases by up to 90%.
Kits are available for HPLC and GC validation, with full traceabilty and 21 CFR part 11 compliance included as standard.
A variety of v-kits are available: for testing single devices such as UV detectors, fluorescence detectors, and refractive index detectors.
Kits are available for full HPLC systems including gradient pumps, detectors, autosamplers, and column thermostats.
Refill packs of consumables are also available for each v-kit.
V-kits contain all the materials, protocols, and instructions required to validate HPLC and GC.
The v-kit software generates reports indicating the outcome of the test procedures and allows users to set acceptance criteria pertinent to their own application.
What are the benefits of v-kits? Developing your own testing protocol is very time consuming and there is always the concern that it may not fully meet current requirements.
Equipment manufacturers offer widely varying standards of OQ testing.
Each v-kit contains tried and tested protocol previously examined by auditors in many different pharmaceutical companies.
V-kit protocol is generic and can be applied to all HPLC and GC systems allowing a common standard to be adopted throughout the laboratory.
Validation is the process of checking the performance of a specific measuring procedure and checking that the performance meets a certain pre-set criteria.
Validation establishes and provides documented evidence that the particular measuring procedure is fit for purpose - as such, it is not an option.
Regulatory agencies such as FDA and MCA demand that laboratories must calibrate instruments at suitable intervals using written procedures. V-kits provide independent confirmation that instruments are performing to the requisite specification.
All materials used have traceabilty back to nationally or internationally recognised standards.
Effective equipment validation is the cornerstone which supports the whole laboratory effort.
Without it, the quality of analytical data will always be in doubt.
