Forensic DNA grade quality

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 18385
• ISO 13485
• USA FDA 21CFR Part 820
• Medical Device Audit Program (MDSAP)
• MHLW Ministerial Ordinance No. 169 of Japan
• Directives including (IVDF)-Regulation EU 2017/746
• 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.

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. In compliance with the ISO18385 standard section 5.4, QIAGEN evaluates and selects suppliers only based on their ability to supply products in accordance with QIAGENs requirements. They 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 (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 portfolio for qPCR and multiplex STR PCR undergo negative control testing (no-template control). Only kit lots meeting the specifications are released for sale.

Since 2005, QIAGEN has maintained a staff DNA profile database managed by an independent custodian from a German forensic institute. This database comprises anonymous STR profiles of staff working in operations at all our international locations, where testing reagents and plastics for the ''Investigator'' product line are produced. It is regularly updated. The service works on a per-request basis and is open for our customer base worldwide. Inquiries can be initiated by reporting STR profiles to the QIAGEN Technical Service team at www.qiagen.com/exclusiondatabase. For your convenience, please find the Profile Summary Report consisting of individual profiles either reported to be found in an Investigator-branded product and matched with QIAGEN’s staff elimination database, or observed independently by more than one laboratory using QIAGEN products.

Lot-specific Certificates of Analysis (CoA) for Investigator Kits are available on request. They can be ordered online. The CoA documents list the quality controls tested and their acceptance criteria (e.g., determination of enzyme activity, conductivity and performance of buffers, size testing of magnetic particles, etc.).

Investigator Kits are intended for molecular biology applications in forensic, human identity and paternity testing. They are used in forensic casework analysis, and developed specifically for rapid and reliable generation of DNA profiles from blood, buccal swabs and forensic stains. The performance of Investigator Kits is evaluated for various sample types and conditions commonly encountered in forensic and parentage laboratories. Where feasible, the validation study is based on the recommendations of the European Network of Forensic Science Institutes (ENFSI) and the Revised Validation Guidelines of the Scientific Working Group on DNA Analysis Methods (SWGDAM).

¹ Gill, P., Rowlands, D., Tully, G., Bastisch, I., Staples, T., and Scott, P. (2010) Manufacturer contamination of disposable plastic-ware and other reagents—An agreed position statement by ENFSI, SWGDAM and BSAG. Forensic Sci. Int. Genet.