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.
Butterworth Laboratories conducts contract analytical chemistry and quality control (QC) activities for the pharmaceutical industry.
Butterworth’s analysis, method development, validation and stability storage and testing services meet current good manufacturing practice (cGMP) requirements.
Butterworth Laboratories provides independent certification of raw materials, intermediates, active pharmaceutical ingredients (API) and finished products as an economical option.
The company has extensive experience working with pharmacopoeial monographs, including European (EP) British (BP) United States (USP) and Japanese (JP), internationally published standards, client supplied or in-house developed methods.
Traditional techniques such as titrimetric, gravimetric and colourimetric analysis are a core competency requirement for the laboratory staff.
State-of-the-art instrumentation compliments these and ensure the laboratory provides the most up-to-date and economical analytical services.
With a wealth of experience in QC testing, Butterworth is able to bring together, both expert understanding of the technique employed and the practical working knowledge of the analysts to ensure successful method development robust enough for quality control purposes.
Following the development of a method, it is vital that performance is fully validated. Butterworth Laboratories validates methods to ICH guidelines, which is required by most regulatory authorities.
Performing analysis in collaboration with clients on method validation enables projects to be delivered faster, with the benefit of increased robustness and ruggedness.
Butterworth regularly verifies existing methods and transfer methodology in-house from customers or back to the following development.
The nature of stability studies makes them ideal for outsourcing.
Assistance is provided in the design of standard real-time studies, stress testing over short periods at elevated temperatures and photostability studies, in compliance with ICH guidelines.
Butterworth can handle the storage of samples, as well as the associated analysis. Services also include testing samples, which are stored at the client’s own facility.
Butterworth is routinely inspected by the Medicines and Healthcare Regulatory Agency (MHRA), US Food and Drug Administration (FDA), and United Kingdom Accreditation Service (UKAS) on GMP, good laboratory practice (GLP) and ISO: 17025 standards, as part of its commitment to meeting the requirements of the pharmaceutical industry.
The company’s core values are quality, reliability and confidentiality in analytical chemistry outsourcing.
Butterworth aims to meet clients’ needs in a fluctuating environment by understanding their business through regular communication.
Clients are continuously engaged through meetings to discuss current and future requirements, and access will be available to analysts during analysis.
54-56 Waldegrave Road, Teddington