UK: +44 (0) 1925 737 237 US: +1 (307) 264 1572 info@perfectusbiomed.com

ISO 9001 CERTIFIED, UKAS ACCREDITED ISO 17025, GLP

 

QUALITY ASSURANCE 

Perfectus Biomed Group are dedicated to providing a high-quality service to our clients.

Our services are underpinned by our Quality Management Systems, which ensure the confidentiality, impartiality, quality, and integrity of our laboratory studies by ensuring product and service quality levels, customer satisfaction and company objectives are achieved. Perfectus Biomed can carry out studies to GLP (Good Laboratory Practice), we have a range of accredited UKAS biofilm methods and work to ISO 17025 and ISO 9001. In addition, we have UKAS accredited ex vivo tissue models, materials testing and standard planktonic methods.

  

For more about our quality management systems in the UK and USA please get in touch

Perfectus Biomed have experience working on data intended for approval by the United States Environmental Protection Agency (EPA), Food and Drug Administration (FDA) and the Therapeutic Goods Administration (TGA).

Our laboratory is audited regularly by Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom Accreditation Service (UKAS), British Standards Institution (BSI) and also by our clients to ensure compliance to each of our quality systems:

Good Laboratory Practice (GLP);

Perfectus Biomed Ltd (UK) are a GLP-compliant laboratory, demonstrating compliance with OECD Principles of Good Laboratory Practice. GLP is a quality control system of the processes and conditions under which non-clinical health and environmental studies are conducted, recorded, reported and archived. The GLP quality system uses a set of OECD principles to assure the quality and integrity of laboratory studies and the integrity of data produced by harmonizing testing procedures.

As a GLP-compliant testing facility, our laboratory and processes are regularly inspected by MHRA, which includes a review of:

  • GLP quality systems
  • Inspection of facilities
  • Audit of completed and on-going studies

Our statement of GLP compliance can be found here.

ISO 17025;

Perfectus Biomed Ltd (UK) were the first laboratory globally to gain UKAS accreditation for six biofilm test methodologies to ISO 17025 (No. 9192); Minimum Biofilm Eradication Concentration (MBEC), CDC Biofilm Reactor, Drip Flow Biofilm Reactor and the Single Tube method. We also have EN 1276 accredited to this standard. In addition, we also have the following UKAS accredited methods Standard Planktonic Methods, Materials Testing , Lung Tissue Infection Models.

UKAS is the recognized accreditation body for the United Kingdom. They assess organizations that provide testing and calibration services to internationally recognized standards. Accreditation by UKAS demonstrates competence and performance capability of the evaluators. The accreditation requires laboratories to demonstrate that they operate a quality system and generate technically valid results to a global standard to provide consistency.

Please see a copy of our UKAS Schedule of Accreditation.

      

ISO 9001;

Perfectus Biomed Ltd (UK) and Perfectus Biomed LLC (USA) are certified by BSI and Platinum Registration INC. ISO 9001. These standards specify the requirements for quality management systems.

The standard is used to:

  • Demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements.
  • Enhance customer satisfaction through effective application of the system.

 

This is achieved by controlling documentation, resources, infrastructure, work environment, equipment and production using a process-based approach. The ISO 9001:2015 certification brings quality and continuous improvement into the business to achieve the intended results in accordance with the quality policy and strategic direction of the organization. The standard introduces risk and opportunity management to identify business opportunities that contribute to bottom line improvements.

Please see a copy of our UK ISO 9001 certificate.

Please see a copy of our US ISO 9001 certificate.

 

quality management systems

                               

Perfectus Biomed offer GLP-compliant, UKAS-accredited in vitro testing to provide the data required to support products through global regulatory processes. Our expertise and knowledge are fundamental to the services we provide. Please get in touch for further information.

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We are happy to help with your microbiological requirements and with any other queries you may have.

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Perfectus Biomed Group, innovative science, improving lives. We are a UKAS accredited microbiological contract testing company, supporting a global client base from laboratory’s based in the UK and the US.
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