West Yorkshire Pharmaceutical Manufacturer introduce LIMS system
Thornton & Ross Ltd is the largest pharmaceutical manufacturer in the UK. The Huddersfield based company develop well known over the counter healthcare products such as Covonia, Hedrin, Setlers and Mycota, as well as prescription products.
In an effort to consolidate and improve a series of overwhelming existing practices to collate large and increasing volumes of laboratory test data, Thornton & Ross introduced a LIMS system into the quality control laboratory.
A LIMS system, otherwise known as a Laboratory Information Management System, is software that allows laboratories to manage samples, test results and associate data to improve lab productivity. The result … improved accuracy, efficiency and management across the lab.
In terms of challenges, Pharmaceutical Quality Control Laboratories have an important function in raw material evaluation and in production and can significantly impact overall manufacturing performance. Enhancing laboratory productivity leads to improved efficiencies in manufacturing and laboratory operations.
At Thornton & Ross, a requirement was identified for a way to control, manage, organise, document, analyse and report information in an effort to lead to improved efficiency and functionality of data storage and manipulation.
The system needed to be able to manage data for a wide range of analytical techniques for both the raw materials and finished products teams. These include high performance liquid chromatography, gas chromatography, thin layer chromatography, UV spectroscopy, IR Spectroscopy, nuclear magnetic resonance spectroscopy and a range of gravimetric measurements, potentiometric titrations and sample preparation techniques.
Raw materials and finished products conform to European pharmacopoeia and relevant product licenses. All tests are carried out in accordance with the ‘Orange Guide’ (Rules and Guidance for Pharmaceutical Manufacturers and Distributors, compiled by the Medicines and Healthcare Products Regulatory Agency, London, UK), so the LIMS must be compliant with all of the relevant regulations and practices. The software would be used to generate Certificates of Analysis and monitor lab efficiencies whilst trending results for the finished products team. It was also required to speed up processes that are currently very time consuming.
Matrix Gemini LIMS from Autoscribe Ltd was the chosen solution as it met all of the requirements and Thornton & Ross already had experience of using an earlier version of Matrix Gemini for stability testing. Matrix Gemini is a configurable LIMS solution that requires no coding to create a system that matches the specific requirements. Thornton & Ross now have much more efficient reporting, product evaluation and generation of validation documents. All achieved under the original budget estimate