Quality Control 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 Hygiene
SOP-01-106 Acceptance of Biological Ingredients and Cell Lines for Manufacturing
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 Review 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-20-106 Management of Environmentally Sensitive Materials During Equipment Failure
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 Shipment of Final Product Material from Waisman BioManufacturing
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-34-202 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 System: 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-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 series Equipment Operation and Maintenance SOP’s
SOP-52-100 Set-up and Packing of Amersham BPG Columns
SOP-52-101 Cleaning and Changeover of the Chromatography Equipment 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-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