SOP Request

• Changeover Procedure between Cellular Therapy Products
• Cleaning Procedures for the GMP Cell Processing Facility
• Facility Cleaning
• Facility Cleaning and Waste Disposal

• Deviation from Written Procedures
• Deviation Management Program
• Variance and Incident Reports

• Decontamination of Material and Equipment
• Environmental Monitoring (3 SOPs)
• Gowning for Controlled Environment Areas
• Technical Procedure Template

• Cell Therapy Training
• Employee Training Program
• Personnel Training
• Retrospective Documentation of Training

• Batch Record Review
• Corrective and Preventative Action
• Laboratory Out of Specification Investigation Procedure
• Laboratory Patient Chart Review and Product Release Policy
• Quality Assurance Review

• Change Control Program
• Document Change Control
• Documentation System
• GMP-GTP Manufacturing Facilities Quality Management Plan
• Preclinical Study Progress Report
• Product Quality Assurance Program and Release and Return of Clinical GMP/GTP Product
• Product Receipt and Inspection
• Quality Management Program
• Quality Manual
• Receipt and Inspection of Reagents, Media and Supplies
• Receipt and Issue of Cellular Product for Pre-Clinical Studies
• Request for Processing and Releasing of Product
• Transport and Storage of Hematopoietic Progenitor Cell Products
• Transportation of Cryopreserved Cells
• Transportation of Cryopreserved Cellular Therapy Products
• Transportation of Non-Cryopreserved Cellular Therapy Products

• Document Control and Generation and Management of Standard Operating Procedures
• Standard Operating Policies, Processes and Procedures (SOPs)
• Standard Operating Procedures

• Equipment Installation and Qualification
• Equipment Qualification
• Material and Equipment Specifications
• Ordering Materials
• Process Validation
• Supplier/Vender Qualification
• Validation
• Validation, Verification and Qualification Program
• Vendor Qualification Process

Association of Academic Biologics Manufacturers (AABM) is a cooperative network of non-profit academic based biologics manufacturers serving as a national resource to bring together clinical investigators with manufacturing capacity and expertise, develop and share facility operations expertise amongst members, provide quality, manufacturing and regulatory training opportunities, and hold annual meetings. AABM has assembled a library of SOPs that are available to registered members. The available SOPs cover such areas as facility operations, biological waste management, good documentation practices, document control, employee training policies, and gowning. Register to become a member or register your facility and receive access to these SOPs at www.aabmonline.org. There is no fee to register.

The Biopharmaceutical Development Program (BDP) at the Frederick National Laboratory for Cancer Research (FNLCR) provides resources and expertise for development of investigational biological agents. The BDP supports feasibility through development and Phase I/II cGMP manufacturing plus regulatory documentation. The BDP has over 300 documents online that are available free for any investigator, company, or group developing biopharmaceuticals. These documents are useful to scientific, clinical manufacturing, quality control and quality assurance professionals.