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Section: Core Facility
Subject: Standard Operating Procedures / Policies
Facility Director initials with date to evidence annual review. Initials must be in the left hand box at page
bottom, directly beneath the file name and location information. A new initial and date must be made for
each year an SOP is in service.
2. SOP OUTLINE
The text of all SOPs shall be placed in the central area of each page, follow the outline detailed
below. Each required section of the procedure is to be outline numbered with roman numerals
and typed in bold face type and all caps (e.g. ‘II. PRINCIPLE’).
If any section does not apply to a particular procedure, write “N/A” or “Not Applicable” under
the section. None of the required sections may be deleted from a written SOP.
The specific sections which must be included, and the information they must contain are as
follows:
I. NAME OF PROCEDURE/POLICY: The specific name assigned to the SOP. The title must contain
sufficient wording to be unambiguous.
II. PRINCIPLE: The objective of the procedure or policy and the general process or method used, if
applicable must be written. A list of keywords may be appended to this section to aid in searching.
III. SPECIMEN: List specimen type and/or source material.
IV. RESOURCES: Identify all forms and essential additional SOPs that are associated with the SOP. List
all equipment and what laboratory area needs to be employed for the procedure.
V. SUPPLIES AND REAGENTS: List all supplies and reagents needed for procedure.
VI. POLICY / PROCEDURE: Concise, clear description of each step of the procedure or each point of
the policy. Describe in detail the steps to be followed in order to perform the procedure correctly.
Procedures must be written in sufficient detail so that anyone with the appropriate background can read
the SOP, follow it, and arrive at the intended outcome or end product.
VII. EXPECTED RESULTS/TROUBLESHOOTING/CORRECTIVE ACTION: A description or
explanation of how to read, score, record results and interpretations, when applicable will be written in
the SOP. Examples of calculations will be included in the SOP. Expected ranges (normals) will also be
defined, when applicable. Steps to take to troubleshoot instances of incorrect or out-of-range outcomes
should be included when possible. A complete list of corrective actions, including notifications and record
keeping requirements must be included.
VIII. RESULT REPORTING: Specific directions as to how the results of the procedure and the
conclusion are to be reported manually and/or electronically.
IX. DISCUSSION OR LIMITATIONS: Key notes or special comments on factors that may critically
affect the procedure.
X. QUALITY CONTROL: Specific parameters to be monitored during processing or policy
implementation by the performing personnel.
XI. DISTRIBUTION: A list of the specific manuals within the facility that the SOP must be included in. If
appropriate, the statement ‘All Cell Therapy Area SOP Volumes’ may be used.
XII. REFERENCES: Specific citations that substantially support the policy / procedure and its objective.
Wherein appropriate, standards and regulations should be cited.
XIII. SOP HISTORICAL OUTLINE: A separate last or second to last (depending on the presence or
absence of appendices) page of all SOPs shall contain a tabular outline showing the inception, revisions
and personnel making revisions over the entire history of the SOP. The information required in this table
is described in the following subsection.
File name:
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POLICIES & PROCEDURES
