Forensic DNA grade quality
QIAGEN Quality Management System
QIAGEN operates an effective quality management system (QMS) to ensure consistent delivery of high-quality products. Our systems are designed and maintained according to regulatory requirements defined by leading QMS standards, including ISO 9001
- ISO 13485, ISO 13485 under CMDCAS
- USA FDA 21CFR Part 820
- MHLW Ministerial Ordinance No. 169 of Japan
- Directives including MPG (BGB1IS.3146), IVDD 98/79 EC,MDD 93/42/EEC
- Technical Cooperation Program (TCP) Taiwan
- Other international regulations and standards
As part of the stringent and process oriented quality management system, all Investigator Kits are manufactured in an ISO-certified facility. This ensures that they comply with the applicable regulatory requirements. To further ensure consistent high quality, each kit lot is tested against predetermined specifications. QIAGEN aims to continually improve the quality of our solutions and services, to guarantee complete customer satisfaction.
Production and supplier quality standard
All Investigator Kits are manufactured in clean rooms that comply to ISO 14644 standard (minimum standard: ISO class 8) and EU Guidelines on Good Manufacturing Practice of Medicinal Products for Human and Veterinary Use. Critical operations are performed under laminar flow with HEPA filters.
As the quality of raw material supplies can impact the final kit quality, QIAGEN has established a program for the selection, evaluation and re-evaluation of suppliers, contractors and service providers. Suppliers are regularly subjected to inspections and audits, and their certifications are reviewed periodically. Quality assurance agreements are finalized only with suppliers whose materials, equipment and services meet QIAGEN’s quality demands and standards.
Automated manufacturing and EO treatment
Automated manufacturing and EO treatment (where applicable)
Handling and primary packaging of chemicals and consumable devices are conducted, where feasible, on automated production systems. QIAGEN also employs ethylene oxide (EO) as an additional measure to control exogenous DNA in the manufacturing process. These products are labeled accordingly, with ''Forensic DNA Grade EO'' seals. QIAGEN continually monitors the applicability of EO treatment and progressively expands its utilization for Investigator Kits and relevant finished plastic accessories.
Risk analysis of manufacturing processes for potential exogenous human DNA
QIAGEN maintains an ongoing process for identifying, estimating and evaluating the risk to introduce human DNA contamination into products, controlling these risks and monitoring the effectiveness of controls. Therefore, QIAGEN collects and periodically reviews relevant product and process information to evaluate if any previously unrecognized risks are present or if a previously identified risk is no longer acceptable. If either of these occurs, the impact on previously implemented risk assessment and control measures are evaluated and the risk control measures are updated as necessary.
Post-production testing for absence of human DNA
QIAGEN’s quality control system includes a release process that tests the performance, reproducibility and absence of exogenous human genomic DNA in finished lots of Investigator Kits. Exogenous human genomic DNA is quantified by a sensitive real-time PCR assay that amplifies highly ubiquitous human DNA sequences. All kit components of the Investigator Kits for qPCR, multiplex STR and DIP/InDel PCR undergo negative control testing (no-template control). Only kit lots meeting the specifications are released for sale.