Highest degree of product Quality

It is the policy of bioTRADING to achieve the highest degree of product quality, ensuring that processes and services are continuously improved and in line with international standards and customer requirements. 

ISO/IEC 17025:2005 - ISO 11133:2014

Our QC lab, performing the quality control of all batches Ready Prepared Culture Media, is accredited by the Dutch Council of Accreditation (reg.nr. L588) in accordance with the recognised International Standard ISO/IEC 17025:2005 'General Requirements for the competence of testing and calibration laboratories'.  The accredited methodology is conform ISO 11133:2014 Click here for the ISO/IEC 17025:2005 declaration. Click here for press release.

ISO 9001:2008

The company's total commitment to quality and performance was reflected in 1994, when bioTRADING successfully achieved ISO 9001 accreditation. Furthermore, partly due to many external audits being regularly undertaken at our facility, our quality management systems is adapted to GMP. Click here for the ISO 9001:2008 certificate.

Harmonized USP/EP/JP

Our Ready Prepared Culture Media meet the harmonized USP/EP/JP formulations and performance criteria*.

Quality Control

Extensive quality control for sterility and bacterial growth parameters among others are carried out by our laboratory. Every batch of media is tested to international standards or to customer specifications. Organism challenges and sterility testing can be tailored to duplicate your present in-house methods, saving the customer a lot of time; less quality control to be performed by the customer.
Quality Control Certificates can be downloaded using a login password.

FDA compliant

Our facility- and environmental-monitoring systems (including microbiological- & partical measurement) are ‘FDA 21 CFR Part 11 compliant’.

State-of-the-art production facility

The new ultramodern production facility in Mijdrecht, opened in 2009, is designed and equipped to meet pharmaceutical regulations, for Ready Prepared Culture Media. For the production of Ready Prepared Culture Media we use some of the most advanced equipment available, including: magnetic stirred media preparation vessels, water cascade autoclaves, multi-lane pneumatic petri dish filling machines, 2-D-datamatrix barcodes and more. We produce in cleanrooms class 5 to 8 (conform ISO15644-1).

Audit report quotes

  • 'The quality documentation system of bioTRADING is meeting the current ISO and GMP standards.'The quality documentation system of bioTRADING is meeting the current ISO and GMP standards'.
  • 'A strongly developed computerized system controls orders, the process, delivery to customers as well as quality and traceability of microbiological media'.
  • 'Hygiene, housekeeping, storage space and routing were seen as very impressive, bioTRADING clearly demonstrated to have quality high in their standard'.
  • 'The routing of raw materials to end products is very well organized'.
  • 'All critical process steps are automatically monitored and controlled'.
  • 'Equipment is validated and maintained on a regular basis and records are kept'.
  • 'Traceability is assured. Traceability is possible up-stream as well as down-stream'.
  • 'Every raw material and end products including process runs can be traced to the customer'.
  • 'The appropriate quality, scientific and technical knowledge of the participants was experienced during the audit'.
  • 'The plant was found to be well designed for its purpose'.
  • 'The impression of the employees was motivated and alert personnel who were very well trained for their jobs'.
  • 'The standard operating procedures reviewed during the tour were impressive and detailed the processes effectively, including flow diagrams were appropiate'.
  • 'The facility was extremely well organised and maintained'.
  • 'The facility was well designed, orderly and clean'.
  • 'Based on our audit, the Excellence status has been given to bioTRADING'.
  • The manufacturing areas were 'inbuilt' design and process flowed well'.
  • 'The auditors concluded that the quality of the products manufactured by bioTRADING is assured by the procedures and the quality system in place'.
  • 'The audit team can confirm that bioTRADING complies with our standards for GMP suppliers'.
  • 'The audit gave an impression of a company that has a very good understanding of the pharmaceutical industry and our requirements.'
  • 'The auditor observed that bioTRADING premise is a state of the art manufacturing facility'.
  • 'Both facilities and Quality Management System were found to be impressive and very well managed'.
  • 'bioTRADING maintains the documentation and overall control to a very high standard'.
  • 'bioTRADING has very nice facilities which are at a standard similar to pharmaceutical production facilities'.

 

     
     

(*where applicable)