Quality

Life Science Molecular Diagnostics GMP BioManufacturing


Our Quality Management System (Belgian site) is fully certified to the ISO13485:2003 Quality Standard and compliant with FDA’s Quality System Regulation (21 CFR 820).

The GMP facility incorporates a card-key system for access to the manufacturing floor and permits full segregation of synthesis, cleavage/deprotection, purification and fill & finish processes.

Acces of the various clean rooms of various classes (class 100,000 and 10,000 with class 100 working zones) requires airlock pass-through and gowning policy.


Highly Controlled Upstream Process Control

  • Each supplier is carefully screened and approved
  • All reagents undergo rigorous Quality Control testing to guarantee exceptional quality and reproducibility of the finished product

Quality Systems

We have built a strong and comprehensive cGMP quality system over the past 15+ years:

  • cGMP manufacturing authorization since 1993 for our recombinant protein and vaccine production. Over 70 products prepared for phase I and phase II clinical trials
  • Current ISO 9001:2000 certification
  • Quality Management System certified to ISO 13485:2003 and compliant with 21CFR Part 820 standards
  • Rapidly growing portfolio of diagnostic and service laboratory partners in Europe and North America

Quality Management System

  • High level of education and training 
  • Strict process segregation and employee gowning policy
  • Supplier qualification and evaluation 
  • Comprehensive Batch records with full traceability
  • IQ/OQ/PQ maintenance and calibration standards
  • Dedicated equipment
  • Stringent document change control procedures
  • Deviation management
  • Process control
  • Exhaustive analytical method validation
  • Critical analysis & documentation rationale
  • Independent QC department for assuring exact specifications prior to release
  • Routine internal audits
  • Customer quality audits
  • Sample retention to facilitate troubleshooting
  • Quality Agreements and/or Supply Agreements as extension of the manufacturing contracts to clearly define our responsibilities to our partners

Customized QC Release Methods

In partnership with our customers, we develop a QC Release Methods Repertoire customized for their specific requirements. We offer exceptional flexibility by providing a large selection of standard and customized QC release methods any of which can be incorporated into their customized repertoire.

 


Typical QC Release Methods

  • Final mass determination (release by O.D., μmols, weight)
  • Physical inspection of product
  • MALDI-TOF or ESI Mass Spectrometry
  • HPLC anion exchange
  • HPLC reverse phase
  • Capillary Gel Electrophoresis
  • Direct sequencing using enzymatic cleavage and MALDI-TOF
  • Enzymatic tests for DNA-enzyme conjugates
  • Probe/dye activity: fluorescence, signal to noise ratio, melting profile for Molecular Beacons
  • Heavy metals
  • Residual solvents
  • pH
  • Water content (Karl Fisher)
  • Endotoxins
  • Bio-burden

 


Certificate of Analysis


Our products are provided with a certificate of analysis, a document detailing the release based on the batch record and signed by the QC authorized person.

Stability Testing



In addition Eurogentec offers stability testing of oligonucleotides following
our standard or customized procedures.

For inquiries, please contact the Eurogentec Diagnostic Oligonucleotides or Taq  team:

Diagnostic Oligonucleotides
 
 Diagnostic Taq
 
Tel.: +32 (0)4 372 74 00
Fax: + 32 4 372 75 00
diagnostic.oligo@eurogentec.com		 Tel.: +32 (0)4 372 74 00
Fax: + 32 4 372 75 00
diagnostic.taq@eurogentec.com


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