Butterworth is a UK based contract laboratory providing pharmaceutical analysis in accordance with cGMP to the global pharmaceutical industry. We specialise in Quality Control, Method Development & Validation and Stability Storage & Testing. Our focus and expertise centre on raw materials but we also have experience of finished products and medical devices.
We have extensive experience in the quality control (QC) analysis of raw materials and finished products in accordance with internationally published (EP, BP, USP, JP), client supplied or in-house developed methods.
The use of classical wet chemistry techniques is a requirement for many QC analyses and a key competency of all of our laboratory analysts as we believe this to be the foundation of a good analytical chemist.
We also have a wide range of state-of-the-art analytical instrumentation to compliment our classical competencies, all of which are maintained and qualified to GMP standards. This enables us to provide the most up-to-date and cost effective analytical services.
We consider ourselves experts in the analysis of excipients and active pharmaceutical ingredients (API), the outsourcing of which can often prove to be a cost-effective option for many companies. Lack of instrumentation and expertise, support through periods of high workload and meeting short deadlines are some of the reasons our customers choose to utilise our services.
We have extensive experience in elemental impurities and residual solvents analysis, two key safety ensuring analyses that require considerable knowledge and equipment investment to perform.
Our wealth of experience in quality control analysis, including practical working knowledge and expert understanding of the techniques employed lends itself directly to the successful development of robust methods for routine quality control analysis.
Method performance is also fully validated to ICH requirements following development. We often perform analysis in parallel with our clients on method validation enabling projects to be delivered in shorter time frames, with the additional benefit of increased robustness and ruggedness.
In addition, we regularly transfer methodology in-house from customers or back to them following development.
Material specific verification of methods is vitally important in demonstrating that an existing validated method is suitable for use with a material and that the method can be successfully performed routinely in the laboratory. It can be as simple as demonstrating that system suitability parameters are met but will be dependent on the technique employed.
We regularly design and set-up real time stability studies under standard controlled conditions as well as stress testing over short periods at elevated temperatures and humidity. We also provide photostability studies, all of which comply with ICH guidelines.
We believe that the best way to meet your needs is to understand your business, the key to this and to delivering a successful analytical service is good communication. We value meeting with our customers to discuss their current and future requirements, and you will always be able to speak directly to the analyst performing your testing.
We are committed to providing the highest quality services and are routinely inspected by the MHRA and FDA as well as our customers for GMP and GLP compliance.
For more information about our services or to request a quotation for analysis, please contact us.