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Section: Core Facility
Subject: Standard Operating Procedures / Policies
I. NAME OF PROCEDURE:
Standard Operating Procedures and Policies (SOPs)
II. PRINCIPLE
The purpose of a Standard Operating Procedure (SOP) for SOPs is to provide uniformity and guidance in
the process of writing, maintaining, and disseminating procedures in a consistent manner in accordance
with FDA, FACT, AABB, and NCCLS guidelines. The purpose of the associated SOP Manual is to
ensure accurate conduct of all Cell Therapy Facility operations, including all processes, policies, quality
functions, as well as to insure compliance with all relevant accreditation and regulatory standards
including FDA, FACT, AABB, CAP, JCAHO and state regulations
III.SPECIMEN N/A
IV. RESOURCES
A. Forms
o xxTF-I-001A New & Revised SOP Draft Review
o xxTF-I-001B Review Training for new revised SOPs
o xxTF-II-009.1 Validation Protocol Form
o xxTF-X-019 Stem Lab Process & Protocol Validation
B. Other Essential SOPs
o xxF-I-002 Process Control
o xxF-I-005 Change Control
o xxF-I-011 Cell Therapy Facility Director – Scope of Responsibilities
o xxF-I-012 Cell Therapy Facility Manager – Scope of Responsibilities
o xxF-I-013 Cell Therapy Facility QA Coordinator – Scope of Responsibilities
o xxF-I-014 Cell Therapy Facility Medical Directors – Scope of Responsibilities
o xxF-X-015 Layout Process & Protocol in Stem Lab
o xxF-X-030 Use of Cell Therapy Facility SOP Template for MS Word
C. Other Resources
o Cell Therapy Facility SOP Template for MS Word
X Lab\SOPs\SOP TEMPLATE
V. SUPPLIES AND REAGENTS N/A
VI. PROCEDURE
A. APPLICABILITY OF THIS SOP
All standard operating procedures / policies of the Therapy Facility which are generated or revised on or
after the effective date of service of this SOP on Standard Operating Policies / Procedures must be
File name:
Page 1 of 16
POLICIES & PROCEDURES
