| 1000 |
Standard Operating Procedures and Forms |
| 1002 |
Employee Training |
| 1003 |
Data Entry and Correction |
| 1004 |
Signature Records and Signing Authority |
| 1005 |
Gowning and Flow for the JVL |
| 1006 |
Formulation Lot Number Assignment |
| 1007 |
External Regulatory Inspections |
| 1008 |
Shipping |
| 1011 |
Sampling Technique |
| 1013 |
Validation Protocol and Report |
| 1014 |
Personnel Hygiene |
| 2001 |
Cell Culturing |
| 2002 |
Cell Thawing |
| 2003 |
Passaging of Adherent Cells |
| 2004 |
Passaging of Suspension Cells |
| 2005 |
Cell Counting and Viability |
| 2006 |
Preparation and Revialing of Adenoviral Vector Dilutions |
| 2007 |
Proportional Aliquoting of Cells |
| 2008 |
Cell Bank Production |
| 2009 |
Freezing Cells Using the Controlled Rate Freezer |
| 2010 |
Preparation of Cells for Adenoviral Vector Transduction |
| 2011 |
Adenoviral Vector Transduction |
| 2012 |
Harvesting of Cells Infected with Adenoviral Vectors |
| 2013 |
Purification of Adenoviral Vectors |
| 2014 |
Desalting of Vector Using the Slide-A-Lyzer |
| 2015 |
Adenoviral Vector Freezing |
| 2016 |
Producing Adenoviral Vector in 10 Stack Factories |
| 2017 |
Plaque Isolation of Recombinant Adenoviral Vector |
| 2018 |
Restriction Analyses of Plasmid DNA |
| 2020 |
Control of Raw Materials |
| 2030 |
Cesium Chloride Preparation |
| 2031 |
Agarose Gel Electrophoresis |
| 2032 |
Production Room Usage |
| 2033 |
Use and Cleaning of Laminar Flow Biological Safety Cabinets |
| 2034 |
Sample Storage and Distribution |
| 2035 |
Receipt of Cell Lines and Viral Vectors |
| 2043 |
Preparation of Plasmid DNA for Further Manufacturing Use |
| 2044 |
Transforming and Plating Bacterial Cells |
| 2045 |
Picking Bacterial Colonies and Freezing Clonal Isolates |
| 2046 |
Expanding, Harvesting and Freezing Bacterial Cells for Cell Banks |
| 2047 |
Gram Stain |
| 2048 |
Detection of DNA by Hybridization |
| 2052 |
Raw Material Specifications |
| 2053 |
Formulation Master Record |
| 2054 |
Product Specifications |
| 2501 |
Batch Record for Production of Cell Banks |
| 2502 |
Revialing Adenoviral Vector Without Vector Dilution |
| 2504 |
Revialing Adenoviral Vector With Vector Dilution |
| 2505 |
Batch Record for Thawing and Redialysis of AAV Vector Preparation |
| 2508 |
Batch Record for Transfection and Harvesting of AAV |
| 2509 |
Batch Record for AAV Purification by Iodixanol Density Gradient and Ion Exchange Column Chromatography |
| 2510 |
Batch Record for Dialysis and Sterile Filtration of AAV Vector Preparation |
| 2511 |
Batch Record for Production of Plasmid DNA |
| 2512 |
Batch Record for Production of Bacterial Cell Banks |
| 3001 |
Cleaning, Maintaining and Monitoring Equipment |
| 3002 |
Preparation of Sanitation and Disinfectant Solutions |
| 3003 |
Cleaning Sequence of the JVL |
| 3004 |
Cleaning and Sanitizing the JVL |
| 3005 |
Equipment Calibration |
| 3006 |
Handling and Maintenance of Pipette Aids |
| 3007 |
Operating, Maintaining and Calibrating the Met One Particle Counter |
| 3008 |
Operating, Maintaining and Calibrating the RCS Plus Air Sampler |
| 3009 |
Equipment Identification |
| 3010 |
Equipment Logbooks |
| 4002 |
Viral Particle Determination by Optical Density at 260 nM |
| 4004 |
Measuring Concentration and Purity of DNA by UV Absorbance |
| 4005 |
pH Measurement |
| 4006 |
Environmental Monitoring |
| 4007 |
GM-CSF ELISA |
| 4008 |
Identification of Environmental Isolates |
| 4009 |
Sample Test Request and Tracking |
| 4010 |
Visualization of Probed DNA by Phosphoimager SI and ImageQuant |
| 4012 |
Viral Purity by Silver Stain |
| 4013 |
Genome Copy Titer by Dot Blot |
| 4014 |
Adenoviral Vector Titration Protocol |
| 4015 |
Identity PCR for Adenoviral Vectors |
| 5001 |
Responsibilities of Quality Assurance |
| 5002 |
Quality Assurance Audits |
| 5003 |
Documenting and Investigating Quality Variations |
| 5004 |
Permanent Change Control |
| 5005 |
Temporary Change Control |
| 5006 |
Clinical Labels |
| 5007 |
Production Lot Number Assignment |
| 5008 |
Product Release |
| 5009 |
Investigating Out of Specifications |
