Custom Biotech Quality Standards
- 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
Quality Management System
In 2011 the Custom Biotech 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.
- cGMP 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
cGMP Products Manufacturing
To meet the requirements in molecular diagnostics and pharma industrial processing, production is regulated by cGMP guidelines.
GMP for Diagnostics Manufacturers
Raw materials are important ingredients for high lot-to-lot consistency, crucial in the manufacture of diagnostic tests. Custom Biotech 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