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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.

Our Quality Policy

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.

Mission

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.

Our Quality Compliance

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:

  • Directive 2003/94/EC applies to medicinal products for human use
  • Directive 91/412/EEC to products for veterinary use
  • FDA U.S. Food and Drug Administration - responsible for protecting the US public health Code Federal Regulation (21 CFR)
  • BS EN ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories

The directives above are written into UK law via “Rules and Guidance for Pharmaceutical Manufacturers and Distributors” – often referred to as "The Orange Guide".

 

Client Audits

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.

Our Quality Certifications

Below is a list of our certifications as a contract GMP laboratory:

MHRA Certificate of GMP Compliance of A Manufacturer

  • For human medicines, veterinary medicines and importation of medicinal products
    • Inspected as a site of QC testing for chemical and physical analysis

View Certificate - Human Medicines >

View Certificate - Veterinary Medicines >

FDA U.S. Food and Drug Administration Letter of Inspection

  • Compliance to current good manufacturing practices
  • No 483 deficiencies observed

View Letter >

Controlled Drug Licence

  • Schedules 2, 3, 4 part 1, 4 part 2 and 5
  • Approval to handle and supply controlled drugs for both testing in the laboratory and storage in stability chambers.

View Licence >

 

Techniques and capabilities

Resources

Case Study

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. 

Case Study

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.

Infographic

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.