QA & Compliance for Pharmaceutical Fortune 500
Million $ Facility
Laboratory Buildout & SOPs
Quality control laboratory buildout – commissioning and qualification of a newly built gene therapy lab from construction to release.
Quality Control Laboratory Buildout
- Commissioning and qualification of a newly built gene therapy laboratory from construction to release
- Required a full time, dedicated project manager, fully staffed validation and computer system validation resources.
- ANSA was tasked with providing full project schedule for timelines of deliverables and resource loading.
- $120 million gene therapy manufacturing facility
- Resources worked with system owners to develop URS, Config Spec, IQ, OQ, PQ, Trace matrix, Summary Reports and full validation project plan.
- Worked with client team to produce processes that were not developed at the time of qualification, so we provided consulting on quality of validation processes, risk assessment processes, csv processes, IT security processes, and system admin processes.
- Qualified over 70 pieces of equipment and instrumentation, including complex systems, enterprise systems and simple systems.
- Worked on implementing work station back up solutions for the site
- Molecular Devices SpectraMax M5 Spectrophotometer w/SoftMax Pro 7 GxP
- Lonza ELx9-9 Microplate Endotoxin Reader w/ WINKQCL 6 Software
- Agilent Technologies Cary60 UV Spectrophotometer w/ Cary WinUV Pharma Software
- Beckman Coulter Met One 3415 & 3445
- Bio-Rad ddPCR system w/ QX Manager Software, Regulatory Edition
- ChemoMetec NucleoCounter NC-200 Automated Cell Counter w/NucleoView Software
- Mettle Toledo SevenExcellence pH/mV and Conductivity meter
- Servomex Company 5200 MiniMP Portable Oxygen Analyzer
- Bioscience International SAS Super 180 Bioaerosol Sampler
- Molecular Devices Plate Washer
- Mettler Toledo Excellence XPR Analytical Balance
- Mettler Toledo Top Loader Balance
Provided Technical Writing Support for the LIMS Implementation Project
- Admin Standard Operating Procedures (SOP)
- General Use (SOP)
- EM (SOP)
- Training Material (PPT)
- On the Job Training (OJT) Forms
- System Risk Assessment
- Configuration Specifications
- Trace Matrix
- Data Integrity Assessment
- Validation Summary Reports
- Validation Plans
- Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documents
- Installation/Operational Qualification (IOQ) Addendums
- Discrepancy Report Forms (DRF)