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Section: Core Facility
Subject: Standard Operating Procedures / Policies
A table of contents containing an ordered list of all of the SOPs within the above listed sections must be
maintained. All original SOPs, with review signatures, validation studies, and training/review
documentation, must be kept on file with the QA unit. Each individual area within the facility (i.e., stem
cell lab, apheresis area, etc.) must have access to the SOP’s by electronic delivery.
C. Electronic copies shall be maintained in read-only format on XXX
All SOP’s will be written in size 12 or 14 font in Times New Roman or Arial font using the box style
pages that the present document is prepared in. A template, prepared in MS Word file format, is available
in the SOP root directory on the network drive. Instructions for use of this template, which includes pre-
defined styles, are in SOP # CTF-X-201 Use of Cell Therapy SOP Template in MS Word.
Following are the elements of the SOP layout, including the areas of the block format on every page, and
the specific sections that all SOPs must contain, and the review signatures that must be present on all
1. COMPLETION OF BLOCKS IN THE PAGE LAYOUT – ALL PAGES
At the TOP of each page must appear the facility name and address, the department name, the
SOP number and the subject of the SOP. If the SOP has been implemented to replace a previously
used SOP, then the SOP superceded must also be identified. The specifics of each of these top of
the page items is as follows:
Facility name and address: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
SOP Number: This is a unique number assigned to the procedure. All SOPs in the Facility begin with the
prefix ‘CTF-’. The second part of the SOP number is the roman numeral denoting the volume it falls
within, followed by another hyphen. The last part of the SOP number is the specific number within the
volume, recorded as a three digit number, including leading zeroes. Procedures which have been revised
beyond the original must also have a revision number, denoted by a final decimal point and revision
number. The complete SOP number takes the form:
CTF-<volume number>-<number within volume>.<revision>
(for example, the second revision of this procedure is “CTF-I-001.2”).
Insofar as practical, procedures should be organized within each volume in a logical sequence and
listed in a master table of contents, plus an individual volume table of contents at the beginning of
each SOP volume. IF AN SOP IS TAKEN OUT OF SERVICE, IT’S UNIQUE NUMBER MAY
NOT BE REUSED.
SUBJECT: Generally, the subject is the specific name assigned to the SOP. For SOPs with long titles, the
subject should be shortened by using abbreviations (for example, the subject for this SOP could be
shortened to ‘SOPs’) and/or by eliminating less informative words in the title (examples, ‘the’, ‘a’, ‘for’).
At the bottom of each page the blocks must have the name and location of the word processor file
containing the SOP text, the page number and the total number of pages, and on the hard copy,
the dated initials of the Facility Director to evidence annual review.
FILE: The computer file name and location on intranet assigned to the SOP, placed at the top of the left
hand box at the bottom of each page.
PAGE: The page and total number of pages, at the lower right corner of each page.
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POLICIES & PROCEDURES