Broughton is focused on the development of innovative scientific programs to deliver quality and regulatory compliance for the companies we work with.
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.
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:
From basic questions to complex compliance inquiries, we're here to help! Contact us today.