Butterworth Laboratories Contract Analytical Chemistry Services and Quality Control Testing
Butterworth Laboratories is a fully independent laboratory providing contract analytical chemistry services to the pharmaceutical and related industries.
Butterworth specialises in quality control (QC) analysis, method development, validation and stability storage and testing, in accordance with current good manufacturing practice (cGMP).
Quality control analysis of raw materials, intermediates, API and finished products
The company provides independent certification of raw materials, intermediates, active pharmaceutical ingredients (API) and finished products which can be an economical option for many companies.
Butterworth have extensive experience working to 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 colorimetric analysis are a core competency requirement for the laboratory staff.
State-of-the-art instrumentation compliment these and ensure the laboratory provides the most up-to-date and economical analytical services.
Method development and validation in accordance with ICH guidelines
With a wealth of experience in QC testing, Butterworth are 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 them following development.
Stability study design, storage and testing
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.
About Butterworth Laboratories
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.
Products and Services
Elemental Impurity Analysis in Pharmaceuticals
A method to identify heavy metals in pharmaceuticals was introduced in the United States Pharmacopoeia more than 100 years ago.
Method Development and Validation
Butterworth uses its expert understanding of techniques employed and practical working knowledge of analysts, ensuring successful method development robust enough for quality control purposes.
Changes to USP Chapter Residual Solvents have affected manufacturers of pharmaceutical products and contract testing laboratories.
Stability Testing for Drug Substances and Products
Stability testing provides evidence on how the quality of a drug substance or product varies over a given time period and under the influence of environmental factors including temperature, humidity and light.
Quality Control Analysis
Independent certification of raw materials, intermediates, active pharmaceutical ingredients (API) and finished products are provided by Butterworth.
Over the past decade or so, the issue of impurities present in pharmaceuticals which may be DNA-reactive has caused regulators and manufacturers significant problems.
Elemental Impurity Analysis in Pharmaceuticals and Implementation of ICH Q3D
Elemental impurities have been a hot topic since 2009 when the International Conference of Harmonisation (ICH) commenced work on a new standard to provide a global policy to limit these impurities in drug products and ingredients.
How Virtualisation Can Help Electronic Data Retention
One of the most discussed topics currently affecting good manufacturing practices (GMP) laboratories, data integrity involves conforming to fundamental elements of quality: attributable, legible, contemporaneous, original, and accurate (ALCOA). Of these, legibility presents a particularly tough challenge.
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