• Security

     

    Trust us to handle your

    project with care

Set your mind at ease
 

Our global reach and state-of-the-art manufacturing mean a secured supply of products and services to drive your business forward, when and where needed. Our stringent standards mean lot-to-lot consistency in narrow specifications so your products meet regulations. Our solutions mean streamlined workflows and traceable quality to strengthen your operational performance.

Learn more what „Security“ means to us

Quality Management System

In 2011 the CustomBiotech Quality Management System (QMS) was switched from ISO 9001 to ISO 13485 certification. This international standard requires an organization to consistently meet customer and regulatory requirements specifically applied to the in-vitro diagnostic and medical device industry.

CustomBiotech raw material and final kit production follows:

  • Detailed documentation (SOPs, central documentation)
  • Batch records with full traceability of all parameters
  • Independent QC and QA departments
  • Change control procedures
  • Complaint handling procedures
  • Education and training programs
  • Supplier evaluation programs
  • Maintenance and calibration programs

ISO 13485:2012 Certificate

GMP Products Manufacturing

To meet the requirements in molecular diagnostics and pharma industrial processing, production is regulated by GMP guidelines.

GMP guidelines include:

  • Validation
  • Equipment
  • Processes, including filling
  • QC procedures (extended testing)
  • Stability programs
  • Cleaning procedures, dedication concept
  • Hygienic environment
  • Continuous monitoring
  • Clearly defined hygienic zones
  • Established change control notification (CCN) procedures 
GMP for Diagnostics Manufacturers

Raw materials are important ingredients for high lot-to-lot consistency, crucial in the manufacture of diagnostic tests. CustomBiotech has developed a proven line of raw materials for molecular diagnostics products using GMP guidelines

Products for molecular diagnostics:

  • Primers and Probes
  • Nucleotides
  • NTPs, Molecular Diagnostics Grade

 

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