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Quality

Finding the right partner to work with is always difficult.  Does the company have the right experience and certification?  Does their business culture give you confidence in the quality of their service delivery and test results? Do they strive to deliver continuous learning and improvements based on clearly defined quality processes?  Would they welcome a site visit and be happy to let you audit their facilities? 

Whatever your questions, we are happy to share the information you need to make the right decision for your business. 

ISO 17025

Our Oak Tree House facility is a UKAS accredited testing laboratory No. 10636. We are inspected annually by UKAS to ISO 17025:2017 General requirements for the competence of testing and calibration laboratories to assess our ability to produce precise, accurate tests and data, including the technical competence of our team, 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 the UK 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.

Modern analytical testing laboratory with lab equipment (1)
Broughton Oak Tree House Lab

GMP Compliance

We have two in-house analytical facilities based in the United Kingdom and service a range of global clients. Our Coleby House facility is compliant with the UK GMP (Good Manufacturing Practice) and U.S. CGMP (Current Good Manufacturing Practices) standards. It is inspected by the Medicines and Healthcare Products Regulatory Agency (MHRA) and U.S. Food and Drug Administration (FDA). 

Client Audits

Your business success depends on working with partners you trust.  

  • We encourage new clients to visit our facilities and meet the team  
  • We welcome client audits and see them as a chance to build understanding and share knowledge
  • We work with you as one integrated team on technical troubleshooting
  • We conduct project reviews and learning workshops both during and at the end of each project.



Client audits are a knowledge-sharing exercise and help us align objectives, ideas, and interpretations of regulations to ensure we deliver to your requirements and can become an extension of your in-house team.

Having gained over 15 years of experience in the auditing process, we enjoy hosting audits and welcoming new and existing clients to our facilities. An audit is an opportunity for you to gain insight into our culture and way of working. It allows you to tour our facilities and interact with the technical team that will work on your project. The audit also enables you to have complete confidence that your samples will be handled, tested, and released in a controlled manner and enables us to highlight our commitment to our Quality Management System and regulatory compliance within our facilities.

Broughton Scientist Working at Computer EDIT 3

Communications

Chasing for communications on test results or waiting to hear about a project update causes your team delays. We ensure ongoing communication is proactive, timely, and from a subject matter expert that understands your project. You will have a named point of contact within the laboratory or project management team to talk to. Communication is vital to excellent customer service, and we put it at the heart of building a one-team mindset with our clients.  

Sample Handling

Quality control starts the moment you ship your samples to us. Whatever your testing requirements, you can trust us to handle your samples in line with GMP or ISO 17025 requirements for sample management, including expectations around traceability, temperature controls and data logging, storage, limiting cross-contamination, data integrity, and computerized systems. These processes are regularly audited and independently verified.  

Learn more about our sample handling process. 

Regulatory Inspections

Our in-house laboratory testing facilities are regularly inspected by the Medicines and Healthcare products Regulatory Agency (MHRA), U.S. Food and Drug Administration (FDA), and the United Kingdom Accreditation Service (UKAS). 

A Quality Culture 

Helping deliver effective quality management for clients in regulated industries enables us to develop long-term strategic partnerships. Our internal Quality Management System is accredited to ISO 17025:2017 and compliant with GxP Guidance. Quality is embedded into our company culture and processes.   

High levels of customer service and communication are also essential to building trust. When issues or complaints do occur, we react swiftly, and investigate thoroughly, working to understand through Root Cause Analysis (RCA) techniques and putting in place effective Corrective and Preventive Actions (CAPA) to improve and monitor while always ensuring high levels of transparency with the client in question. 

Confidentiality is a vital part of our industry, and we will always ensure discretion in everything we do. 

Broughton scientist working at a computer

Speak to an Expert

Arrange a meeting with the Quality Team to learn more about our certification and quality management system.

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Quality Certification

Our Quality Management System is accredited to ISO 17025:2017 and compliant with GxP Guidance, and we look to adhere to the following industry regulations to ensure we maintain patient safety:

Quality Certification

MHRA Certificate of GMP Compliance

FDA U.S. Food and Drugs Administration

UK Controlled Drug Licence

Quality Certification

Directive 2003/94/EC applies to medicinal products for human use

Directive 91/412/EEC to products for veterinary use

The directives above are governed by UK laws The Human Medicines Regulations 2012 and The Veterinary Medicines Regulations 2013 respectively.

MHRA Good Laboratory Practice Regulations 1999, Statutory Instrument 1999 No. 3106 as amended by the Good Laboratory Practice (Codification Amendments Etc.) Regulations, 2004

OECD Principles on Good Laboratory Practice ENV/MC/CHEM (98) 17 (Revised in 1997, Issued January 1998)

FDA U.S. Food and Drug Administration - responsible for protecting the US public health Code Federal Regulation (21 CFR)


Quality Resources  

Quality-Policy

Quality Policy

We believe that the sectors we work within expect a continually improving service where we constantly strive to improve processes and Quality.

Click to download

Quality FAQ

Is the Quality team independent?

 Yes, it is. The Quality Department report to the Director of Quality and is independent of the Operations and Consultancy teams.

How do you ensure a Quality culture?

As an organisation, from day one, quality is introduced to all our employees through induction training.  It is then reinforced through in-role interactive development, specific training programs, and quality team relationships.  All employees across our business are aware of the importance of Quality and regulatory compliance.

Do you include Quality Risk Management (QRM) within the process?

Yes, we do.  QRM is evaluated based on our scientific knowledge, supported by our strong organizational culture, critical thinking, robust data, and our highly trained and experienced staff.

Do you permit customers to audit your quality management system?

Yes, we do.  Please refer to the information above on Client Audits and Contact Us to arrange a site visit.

Do you have a Company Quality Audit Programme to verify procedures and policies are being followed?

Yes, we do.  Each site has a comprehensive self-inspection programme.

Are your facilities accredited to ISO 17025?

Our Oak Tree House facility is a UKAS accredited testing laboratory No. 10636. We are inspected annually by UKAS to ISO 17025:2017 General requirements for the competence of testing and calibration laboratories.

Does Broughton have a complaint handling procedure?

Yes, we do. Continuous learning is a core company value, and we see troubleshooting and issue resolution as an opportunity to improve.  Effective Corrective and Preventive Actions (CAPA) are a fundamental part of the service.

Do you maintain a list of Approved Subcontractors/Suppliers?

Yes, we do.  Our supplier management program ensures outsourced activities are compliant and operate to the same level of quality management that we do.

Do you complete client vendor assurance documentation as part of setting up a contract?

Yes, we do. We will complete client vendor assurance for you and provide any necessary documentation to fulfil your supplier quality needs.

Do you have a controlled process for receiving materials, including inspection, verification, and data logging capabilities?

Yes, we do.  We use Broughton Software LabHQ Laboratory Information Management System (LIMS) to ensure traceability throughout the lifecycle of a sample from receipt to results reporting.

Industry Insight and Expert Opinion

Learn more about our activities and gain insight from our scientific and regulatory experts

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Speak to an Expert 

Arrange a meeting with a scientific or regulatory expert to discuss your project and learn how we can help accelerate your product to market.



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