Standard Operating Procedures

Document#      Title
SOP-01-100     Quality Commitment
SOP-01-101     Waisman Organization Chart and Signature Authority Policy
SOP-01-102     Facility Personnel Flow, Dress Requirements and Hygeine
SOP-01-104     Waisman Project Safety Review and Acceptance
SOP-01-106     Acceptance of Biological Ingredients and Cell Lines for Manufacturing
SOP-01-107     Donor Eligibility and Informed Consent
SOP-02-100     FDA Inspections
SOP-02-101     Client Audits
SOP-02-102     Visitor Policy
SOP-02-103     Equipment Service and Maintenance Policy
SOP-03-100     Corrective and Preventative Action Investigations and Reports
SOP-03-101     Handling of Complaints Concerning Waisman Products and Services
SOP-10-010     Signatures and Signature Cards
SOP-10-100     Document Control: System Definition, Document Issuance and Archiving of Master Files
SOP-10-101     Document Purpose, Numbering Scheme and Appropriate Approval Signatures
SOP-10-102     Standard Operating Procedures: Content, Execution, Form Reivew and Archival
SOP-10-103     Manufacturing Formulas: Content and Execution in Conjunction with Associated Batch
                            Record Documentation
SOP-10-104     Quality Control Specifications: Content and Execution
SOP-10-105     Quality Control Procedures: Content, Execution, Form Review, and Archival
SOP-10-106     Raw Material Receipt Documents: Content Execution, Review, and Archiving
SOP-10-107     Protocols/Reports: Content, Execution, Review and Archiving
SOP-10-108     Recording of Original Data
SOP-10-109     Waisman Laboratory Notebooks
SOP-10-110     Batch Records: Request, Issuance, Review, Return and Archiving
SOP-10-111     Periodical Review of Approved Procedures
SOP-10-200     General Employee Training
SOP-10-201     QC Analyst Training
SOP-10-202     Manufacturing Personnel Training
SOP-13-100     Internal Audits
SOP-13-102     General On Site Vendor Audits
SOP-13-103     Qualifying Vendors Via Audit By Mail
SOP-20-100     Raw Material Receiving, Control, and Release
SOP-20-101     Labeling of Materials and Products
SOP-20-102     Material Vendors: General Requirements
SOP-20-103     Sampling of Raw Materials and In-Process, Bulk and Final Finished Manufactured Product
SOP-20-104     Waisman Receiving of Incoming Materials and Procuring of Raw Materials
SOP-20-105     Biohazardous Material Shipping Guidelines
SOP-20-106     Movement of Materials from Failed Fridge and Freezer Units
SOP-20-200     Bacterial and Fungal MCB Preparation
SOP-22-100     Inventory Control and Disposal of Select Agents
SOP-25-102     Inventory Control of Final Bulk/Finished Manufactured Product
SOP-25-108     Waisman Shipping
SOP-30-100     Clearance to Manufacture
SOP-31-050     Filter Integrity Testing for Terminal Sterilization
SOP-31-052     Method of Cell Transfection via Mirus Trans-IT Transfection Rx
SOP-31-101     Preparation of Tubing Sets for use with Nunc Cell Factories and Bio-Pharm Bags
SOP-31-103     Preparation of Tubing Sets for use with Aseptic Fill
SOP-31-104     Vial, Stopper, and Seal Preparation for use in Small Volume Injectables
SOP-32-100     Preparation of Buffers, Media, & Solutions for Plasmid Manufacturing
SOP-34-100     Plasmid DNA Fermentation and Isolation Procedure
SOP-34-101     Plasmid Pre-purification and Solid-Liquid Separation Procedure
SOP-34-102     Purification of Plasmid DNA by Anion Exchange and Hydrophobic Interaction
                           Chromatography
SOP-34-103     Plasmid Concentration, Diafiltration and Filtration
SOP-34-200     Manufacturing Area Changeover and Use Procedures
SOP-34-201     Changeover Cleaning and Verification for Plasmid Manufacturing
SOP-34-202     Decontamination, Cleaning, Silconizing, and Changeover of Bioreactors
SOP-35-100     Cleaning and Sanitizing the Manufacturing Facility
SOP-35-200     Manufacturing Reprocessing Requests, Review, Approval and Execution
SOP-40-100     Movement of Waste Through the WCBF
SOP-40-200     Pest Control
SOP-40-201     Waisman Secured Access Control
SOP-41-100     Operation and Maintenance of the Emergency Power System
SOP-41-101     Operation and Maintenance of the Rees Equipment Monitoring System
SOP-41-102     Waisman HVAC Environmental Control System
SOP-41-104     Waisman Environmental Control Sysytem: Failure Response, Disaster Recovery, System
                           Security, and Change Control
SOP-41-200     Operation and Maintenance of Process Air
SOP-41-201     Operation and Maintenance of Process Oxygen System
SOP-41-202     Operation and Maintenance of Process Nitrogen System
SOP-41-203     Operation and Miantenance of Liquid Nitrogen Supply System
SOP-41-204     Contracted Maintenance of the Pure Water System
SOP-41-205     Operation and Maintenance of Air Handler No. 2
SOP-41-206     Operation and Maintenance of Air Handler No. 4
SOP-41-207     Operation and Maintenance of Air Handler No. 6
SOP-41-208     Operation and Maintenance of Process Carbon Dioxide System
SOP-41-209     Operation and Maintenance of Lab Exhaust Fans
SOP-41-210     Operation and Maintenance of room 448, South Tower Air Handlers and Exhaust
SOP-42-100     HEPA Filters: Certification and Environmental Control Sysytem Equipment Inspection
SOP-42-101     Water Monitoring: Frequencing, methods, locales, limits, etc
SOP-43-100     Aseptic Processing: Gowning Requirements
SOP-50-100     General Policy for Receipt and Implementation of WCBF Equipment
SOP-50-101     Recordkeeping and Labeling of Equipment as to Status for Use
SOP-50-102     Use of Pipettors and Pipet Aids in Manufacturing and Quality Control
SOP-50-103     Change Control for Waisman Facility Equipment
SOP-50-104     General Policy for Regular Calibration of Wasiman Equipment
SOP-50-105     General Policy for Preventative Maintenance for Waisman Equipment
SOP-50-300     Operation, Maintenance and Calibration of theBraun Biostat C-30
SOP-50-301     Operation and Maintenance of the Carr Continuous Centrifuge
SOP-50-302     Operation and Maintenance of the Process Chiller
SOP-50-303     Operation and Maintenance of the Steris Pure Steam Generator
SOP-50-304     Operation and Maintenance of the PassThrough Autoclave
SOP-50-305     Operation and Maintenance of the Decontamination Autoclave
SOP-50-306     Operation and Maintenance of the CBS Liquid Nitrogen Freezers
SOP-50-307     Operation, Maintenance, and Calibration of the SAS Microbial Air Samplers
SOP-50-308     Operation, Maintenance, and Calibration of the Climet Particle Counters
SOP-50-309     Operation and Maintenance of the Harris Ultra Low Freezers
SOP-50-310     Operation and Maintenance of the Puffer-Hubber Freezers
SOP-50-311     Operation and Maintenance of the Puffer-Hubber Refigerators
SOP-50-312     Operation and Maintenance of the Thermo-forma Model 3130/3110 Water-Jacketed
                            Carbon Dioxide Incubators
SOP-50-313     Operation and Maintenance of the Thermo-forma Model 3033 Series 200 Stericult Incubator
SOP-50-314     Operation and Maintenance of the ThermoForma Reach-In Incubator with
                            Roller Bottle Apparatus
SOP-50-315     Operation and Maintenance of the Bacharach Fyrite Carbon Dioxide Gas Analyzer
SOP-50-316     Operation, Maintenance, and Calibration of the Fisher Sci Digital Thermometer
SOP-50-317     Operation and Maintenance of the Sorvall RC3BP Centrifuge
SOP-50-318     Operation and Maintenance of the Bio-Rad CFX96 Real-Time PCR Detection System
SOP-50-319     Operation and Maintenance of the Dickson Temp Loggers
SOP-50-320     Operation and Maintenance of the Wac-1000 Air Crimp Capping and Decapping Tool
SOP-50-321     Operation and Maintenance of the Drager Gas Detection Pump
SOP-50-322     Operation and Maintenance of the BioTek ELx808 Plate Reader
SOP-50-325     Operation and Maintenance of the Fisher Isotemp Water Baths
SOP-50-326     Operation and Maintenance of the Millipore Water Purification System
SOP-50-328     Operation, Maintenance and Calibration of the Heraeus Microbiological Incubators
SOP-50-329     Operation and Maintenance of the Shimadzu Spectrophotometer
SOP-50-330     Operation and Maintenance of the Agilent HPLC System
SOP-50-331     Operation and Maintenance of the Eppendorf Mini-Spin Plus Micro-Centrifuge
SOP-50-333     Operation and Maintenance of the Fisher Power Supply
SOP-50-334     Operation, Maintenance and Calibration of Balances
SOP-50-335     Operation and Maintenance of the Vaisala CO2 Transmittors
SOP-50-336     Operation and Maintenance of the Terumo Sterile Tubing Welder
SOP-50-337     Operation and Maintenance of Eppendorf Series 2000 Pipettors
SOP-50-338     Operational Qualification/ Performance Verification of the HP1100 HPLC System
SOP-50-339     Operation and Maintenance of the Extech Temperature Logger
SOP-50-340     Operation and Maintenanceof the Simplex Door Interlock System
SOP-50-341     Operation and Maintenance of the SMC Specialty Gas Regulator
SOP-50-342     Operation and Maintenance of the Ashcroft Test Pressure Gauge
SOP-50-343     Operation and Maintenance of the Cole Parmer Test Flow Rotameter
SOP-50-344     Operation and Maintenance of the Invitrogen Mini-Cell Western Transfer Apparatus
SOP-50-345     Operation and Maintenance of the Custom Biogenic System 2100 Series
                            Controlled Rate Freezer
SOP-50-346     Operation and Maintenance of the Flanders Isolator & Steris VHP 1000 System
SOP-50-347     Operation and Maintenance of the Sorvall Legend RT Centrifuge
SOP-50-348     Operation and Maintenance of the Watson Marlowe Pump for Aseptic Filling
SOP-50-351     Operation and Maintenance of the ThermoForma Orbital Shaker
SOP-50-352     Operation and Maintenance of the Venticell Drying Oven
SOP-50-353     Operation, Maintenance, and Use of the Precision Series 280 Digital Water Baths
SOP-50-354     Operation and Maintenance of the Thermo-forma Model 3310 Stericult
                            Carbon Dioxide Incubator
SOP-50-355     Operation and Maintenance EchoTherm Digital Chilling Incubator, Torrey Pines Scientific
SOP-50-356     Operation and Maintenance of the Nikon C-C Phase Contrast Microscope
SOP-50-357     Operation and Maintenance of the ThermoForma Benchtop Incubator Orbital Shaker
SOP-50-358     Operation, Maintenance and Calibration of the Puffer Hubbard BOD Incubator
SOP-50-359     Operation and Maintenance of APV Gaulin Homogenizer
SOP-50-360     Assembly and Operation of Re-usable Glass Bioreactors
SOP-50-361     Operation and Maintenance of the Sorvall Legend RT Centrifuge
SOP-50-362     Operation and Maintenance of the ThermoElectron Model 370 Steri-Cycle
                            Carbon Dioxide Incubators
SOP-50-363     Operation and Maintenance of the Sanyo Laboratory Refrigerator
SOP-50-364     Operation and Maintenance of the Kebby Pro-Seal Air Crimper
SOP-50-365     Operation and Maintenance of Dewars
SOP-52-100     Set-up and Packing of Amersham BPG Columns
SOP-52-101     SCleaning and Changeover of the ChromatographyEquipment Used in Manufacturing
SOP-60-100     Personal Protective Equipment: Selection, Use, Decontamination and Disposal
SOP-60-101     Fire Response, Fire Extinguisher Types, Use and Locations
SOP-61-100     Biohazardous Materials and Bloodborne Pathogens
SOP-61-101     Surface Decontamination and Biohazardous Area Emergency Response
SOP-61-102     Biological Safety Cabinets: Types, Descriptions, and Use
SOP-61-103     Biological Safety Cabinets: Certification for Use
SOP-62-100     Chemical Hygiene Plan
SOP-70-100     Bulk and Final Finished Product Label Preparation, Sampling, Inspection
                            and Reconciliation
SOP-71-100     Deviating from Approved Procedures
SOP-71-102     Expiration Dating and Stability Testing of Manufactured Product
SOP-71-103     Generation, Review, and Release of Waisman Certificates of Analysis
SOP-72-100     Environmental Classifications, Data Trending and Excursions
SOP-72-101     Environmental Monitoring Data Trending
SOP-80-101     Reference Standards: Tests and Specifications
SOP-80-102     Expiration Dating for QC Reagents
SOP-80-103     QC Laboratory Sample Handling, Receipt and Storage
SOP-80-104     Development, Qualification or Validation of Analytical Methods
SOP-80-105     Generation, Review and Release of Analytical Data
SOP-80-106     Investigation of Out-of-Specification or Aberrant Results
SOP-80-107     Testing of Cell Banks for Adventitious Agents
SOP-80-108     Qualification and Use of QC Contracted Service Vendors
SOP-80-109     Glassware Acid Washing
SOP-80-110     Comparison of Commercial Kit and Quality Control Procedure Instructions
SOP-90-100     Application of Validation/Qualification Studies