Quality is an experience that results from the positive habits we maintain to ensure we continually improve and deliver services that meet the expectations of our clients, regulators and employees. Our Quality Policy is the pinnacle of our documentation hierarchy within our quality management system. It is the single document that summarises our commitment to quality and regulations that everyone within our team upholds.
We are an approved GMP compliant facility regularly inspected by both the MHRA and FDA focused on developing strategic partnerships and delivering effective quality management to our clients. Confidentiality is a vital part of our industry and we will always ensure discretion in everything we do.
We are Committed to Quality
We provide our clients with confidence and assurance that their products will get to market through provision of QC batch release testing and regulatory projects. We aim to offer a flexible but comprehensive consultancy service to meet the varying needs of drug development.
It is the teams responsibility to understand and adhere to the Quality Policy.
Compliance is adhering to a given regulation as well as customer requirements. Our Quality Management system is based on ISO 17025:2017, and we look to adhere to the following industry regulations to ensure we maintain patient safety:
The directives above are written into UK law via “Rules and Guidance for Pharmaceutical Manufacturers and Distributors” – often referred to as "The Orange Guide".
We have an open and honest approach and are frequently audited by clients. We like to use client audits as a knowledge sharing exercise and align our ideas and interpretations of regulations to ensure we deliver to their requirements.
We are very established in the auditing process, and we are experienced at hosting audits. As part of the audit process, we also want you to gain a full experience of the Broughton culture. Our audits are not just highlighting our commitment to our Quality Management System and regulations, but it’s also for our clients to tour our facilities and interact with their dedicated technical team which gives them confidence that their samples will be handled in a controlled manner.
Below is a list of our certifications as a contract GMP laboratory:
MHRA Certificate of GMP Compliance of A Manufacturer
FDA U.S. Food and Drug Administration Letter of Inspection
Controlled Drug Licence
Download our case study to read how we helped our client maintain regulatory compliance and extend product shelf-life through our method development, validation and stability management service.
Download and read our case study on how we helped our client reduce production downtime through method development and validation of a 'clean in place' procedure which adequately detects traces of flush solvent.
Wondering how we can help on your drug development pathway? Download our infographic to see where our services can support you from product concept to commercialisation.