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Section: Core Facility
Subject: Standard Operating Procedures / Policies
prepared in compliance with the provisions contained herein. SOPs generated and fully approved and
placed into service prior to the effective date of this SOP may remain in current form until they are next
revised. In pre-effective-date SOPs, significant deviation from the provisions of this SOP may be
grounds for requiring revision, at the discretion of the facility director.
B. ORGANIZATION OF THE SOP MANUAL
The Cell Facility SOP manual shall be arranged in xx volumes, each of which will be assigned a roman
numeral numbering sequence, as shown in the following table:
Number Volume Title Description of Content
I Administration and General Policies SOPs that describe facility organization and
management, functions and responsibilities of all
facility personnel, and common practices for all
laboratories within the facility
II Quality Assurance SOPs that describe the Quality Program and all quality
activities of the facility
III Cell Engineering Laboratory Procedural SOPs for the generation of engineered cell
products, principally for use in immunotherapy
applications
IV Apheresis / Blood and Marrow
Collection
Procedural SOPs specific to the operation of the
apheresis area. Includes SOPs that describe the
activities of cell therapy staff in the harvesting of bone
marrow for transplant.
V Stem Cell Processing Laboratory Procedural SOPs for the preparation of blood and
marrow derived cell products for use as hematopoietic
progenitor cell transplant products or for transfer to
the cell engineering area for generation of engineered
cell products
VI (High Speed Fluorescence Activated
Cell Sorter)
Laboratory planned but not implemented.
VII GLP Laboratory Laboratory in planning process.
VIII Cell Response / Immune Monitoring
Laboratory
Laboratory Planned Procedural SOPs for tests/assays
for monitoring immunologic function in patients on
therapeutic trials.
IX Equipment and Facility SOPs describing the monitoring, cleaning,
maintenance, and calibration of all areas within the cell
therapy facility and all equipment contained therein
X Computers and Data Management SOPs describing the use of specific computer
applications critical to the collection and management
of data generated in the cell therapy facility, and for the
maintenance of all records including this SOP manual.
File name:
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POLICIES & PROCEDURES
