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FDA

Quality & GMP

Fleet Bioprocessing Ltd. operate to ISO9001: 2015 and ISO13485: 2016, and in accordance with the diagnostic GMP requirements of the Quality System Regulations of the US Food and Drug Administration (FDA). You can find our current ISO9001/ISO13485 certification here:
ISO9001 and 13485 certified
Meeting these demanding standards allows our products to be employed for human in vitro diagnostic use throughout the world, including the most highly regulated markets. Needless to say, these standards also allow our products to be employed with the highest confidence in less regulated sectors.
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Some of the key elements of our quality system are:
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  • Version-controlled Standard Operating Procedures describing all key operations.
  • Regular qualification of equipment to approved protocols.
  • Calibration of equipment to nationally-recognised standards.
  • Full training and competence records for all operators.
  • Supplier and raw material approval procedures.
  • Microbiological monitoring and control.
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If you need a full GMP record of the preparation of your product, our Manufacturing Batch Record (MBR) format is purpose-built to meet these requirements.  No more surprise process changes! Fleet will turn your exact requirements into a clearly-defined written procedure, which will be presented to you for approval before the job is carried out. The MBR format, consistent with GMP requirements, allows clear recording of all equipment, material and process information.
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The completion of each key step is recorded by one operator and confirmed by a second - and each completed MBR receives an independent Fleet quality review before the product is released for shipping. Absolutely no changes will be made to the MBR without your approval. In this way Fleet ensures that you receive exactly the product you expected - first time, every time.
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See an example of our MBR documentation format here:
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Where these documentation standards are not required - for example for early development work - Fleet will record all preparative details in "lab notebook" format. While not providing such a comprehensive production record as an MBR, we will always ensure that our write-ups meet ISO9001/ISO13485 requirements, clearly capturing all relevant information and ensuring that the procedure can be repeated with confidence.

Fleet has also been accredited to Cyber Essentials. This is a Government backed scheme designed to prevent against the most common forms of cyber attack. Cyber Essentials provides peace of mind that your data and critical documents are safe against the vast majority of online threats. A copy of our Cyber Essentials certificate can be found here:

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