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Confidence through compliance,
collaboration, and communication
GENEWIZ provides Good Laboratory Practice (GLP) and current Good Manufacturing
Practice (cGMP) regulatory-compliant services for FDA-level applications and
submissions. High quality, reliability, and effortless collaboration with
scientific and quality assurance teams, as well as commitment to excellence and
consistent communication are just some of the advantages GENEWIZ offers.
Regulatory-compliant services available for FDA applications and
submissions include RNA/DNA Identity and Stability Studies for: cell bank,
plasmid, virus, and vaccine. Additional services include Single Nucleotide
Polymorphism (SNP) testing, as well as DNA/RNA preparation for biomarker assays
and validated internal controls.
GENEWIZ Commitment to High Quality & Expertise
Our mission to advance and accelerate life science research by providing
reliable, cost-effective services and high-quality results remain paramount in
our GLP/cGMP regulatory-compliant services. As such, GENEWIZ treats all customer
information, Study-related data, and intellectual property with the same degree
of care and security we do for our own. Transparent communication throughout
your Study with your dedicated expert Study Director reinforces our commitment
to your project's successful completion.
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- GLP/cGMP Services
- Experience
- Quality System
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GLP/cGMP Regulatory-Compliant Services
Final Reports & Deliverables
GENEWIZ provides both electronic and hard-bound reports for
easy
incorporation into regulatory submission files.
Components of customized final reports from GENEWIZ
include, but are not limited to:
- Description of all materials and procedures
- Contig assemblies and graphic Contig overview
- Consensus sequences
- Details of the mutations and insertions/deletions detected
- Raw sequence data with accompanying quality scores
- Certificate of Analysis (COA)
- Signed QAU Statement
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Confidence in the GENEWIZ Experience
Through rigorous planning and proven methodology, GENEWIZ has
gained the trust and repeat business of large, international pharmaceutical
companies and smaller biotechnology companies alike. Together, we design a
project-specific Study Protocol, including scope of work, SOPs, project
requirements, and project deliverables. Both GENEWIZ and the project owner agree
to and sign the Study Protocol prior to implementation.
The GENEWIZ experience includes:
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- Customized services
- Technical consultation and follow-through with a dedicated Study Director
- Validated SOPs, equipment, and facility
- Internal and external audits
- Competitive pricing
- Elements of cGMP compliance (21CFR 211, 600, ICH Q7A) to support
biopharmaceutical manufacturing Quality Control testing
- The GENEWIZ Quality System, developed in accordance with
applicable FDA regulations described in Title 21, Part 58 of the Code of Federal
Regulations for Good Laboratory Practice
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GENEWIZ Quality System
Developed to support GENEWIZ operations, the GENEWIZ Quality
System ensures quality throughout all aspects of our services. For customers,
the GENEWIZ Quality System confirms strict regulatory adherence and consistency
in all of your data.
GENEWIZ quality philosophy ensures that quality is built into all aspects
of our services. As a trusted partner for advancing research and product
development, GENEWIZ constantly strives to meet the needs and expectations of
our customers.
Designed in accordance with the FDA Code of Federal Regulations (CFR), the
GENEWIZ Quality System is compliant with 21CFR 58 and 21CFR 211, 600, ICH Q7A.
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Quality by Design
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- GLP/cGMP regulatory-compliant laboratories
- Regulatory compliance and SOP education
- Method and Assay Validation procedures
- Custom Test Study Protocol Preparation and Reporting for your
specific project requirements
- Vendor Qualification Program ensures all vendors meet GENEWIZ
Quality System standards of excellence
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Quality by Assurance
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- Corrective Action/Preventative Action (CAPA) System:
Identification of problem, the root cause, and continuous improvements in
quality
- Out of Specification (OOS) Investigation System: Investigation
of any unexpected and/or abnormal results
- Quality Trending System: Identification of variations or trends
in data
- Regular internal audits and management reviews
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Quality by Infrastructure
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- Sample Handling and Tracking System: Controls sample check-in,
processing, storage, and disposal
- Restricted-access laboratory compliant with GLP/cGMP regulations
- Installation, Operational, and Performance Qualification
(IP/OQ/PQ) Program: Qualifies all instruments used for GLP/cGMP projects
- On-site fire-resistant data archiving
- Off-site data back-up storage
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Request for Quote/Sample Submission
- To request additional information, please
email
or call us at 1-877-GENEWIZ (436-3949).
- Click here to request a quote via email:
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