Quality

Broughton is focused on the development of innovative scientific programs to deliver quality and regulatory compliance for the companies we work with.

Our team have a successful track record of engagement with both the Medicines & Healthcare products Regulatory Agency (MHRA) in the UK and the Food & Drug Administration (FDA) in the US, on scientific programs for Next Generation Nicotine Delivery Products (NGPs). This includes both the generation of scientific data required for pre-market authorization, and on-going Quality Control (QC) services throughout commercialization.

At the core of our business operations, maintaining an inherent culture of quality is key to our commitment to clients. Regulatory agencies expect manufacturers to be proactive in their efforts towards the development and manufacture of consistently safe products. Our history of quality compliance with global regulatory bodies enables us to add value to the NGP sector throughout their supply chain operations.

ISO 17025:2017
Our Earby facility is a UKAS accredited testing laboratory No. 10636. We are inspected annually by UKAS to ISO 17025:2017 to assess our ability to produce precise, accurate tests and data including the technical competence of staff, the validity and appropriateness of test methods, the suitability and maintenance of test equipment and the quality assurance of test data. UKAS is the national accreditation body for the United Kingdom, appointed by government, to assess organizations that provide certification, testing, inspection and calibration services. Our accreditation is limited to those activities described on our UKAS schedule of accreditation found here.
GLP compliant
Our facility is a member of the UK GLP (Good Laboratory Practice) compliance monitoring programme and we are regularly inspected by the MHRA. Our sister company within the Broughton Group also operates to the UK GMP (Good Manufacturing Practice) standard, and is inspected by both the MHRA and FDA.
Client audits
Our culture is open and honest. We welcome client audits as a valuable continuous improvement activity.
Confidentiality
assured
We are focused on developing strategic partnerships and delivering effective quality management to our clients. Client confidentiality is a key part of our quality system.
Tobacco Product
Master Files
Our team are experienced in compiling Tobacco Product Master Files (TPMFs) to support submissions to the FDA.

Resources

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