Research Support &

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WRITING STANDARD OPERATING PROCEDURES (SOPs)
Raymond C. Anderson, PhD
When Wednesday, August 23, 2006 900
1100 am Where Biomed I Room 205/207
Research Support Regulatory Affairs Quality
Assurance Unit
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WHAT IS AN SOP?
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WHY WRITE SOPs?
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• GOALS
• Define what is an SOP
• State reasons for writing SOPs
• Describe the different formats for SOPs
• Describe how to write an SOP

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WHAT IS AN SOP?
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WHAT IS AN SOP? Standard operating procedures
are a set of instructions having the force of a
directive, covering those features of operations
that lend themselves to a definite or
standardized procedure without loss of
effectiveness. en.wikipedia.org/wiki/Standard_Op
erating_Procedures
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WHAT IS AN SOP? An SOP is a set of instructions
or steps someone follows to complete a job
safely, with no adverse impact on the environment
(and which meets regulatory compliance
standards), and in a way that maximizes
operational and production requirements. Kenneth
A. Friedman, PhD Department of Journalism and
Communication Lehigh University, Bethlehem, PA
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WHAT IS AN SOP? An SOP is a set of written
instructions that document a routine or
repetitive activity. EPA Quality
System Frequent Questions Standard Operating
Procedures (SOPs) www.epa.gov/quality/faq7.html
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WHAT IS AN SOP? SOPs Detailed written
instructions to achieve uniformity of the
performance of a specific function. ICH E6
Good Clinical Practice Consolidated Guidance
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WHY WRITE SOPs? To provide people with all the
information necessary to perform a job properly
(i.e. a training tool) To ensure that the
procedures are performed correctly and
consistently To ensure compliance with
university and government regulations
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WHY WRITE SOPs? To serve as a checklist for
auditors To serve as an explanation of steps in
a process so they can be reviewed in accident
investigations. To serve as a historical record
of the how, why and when of steps in an existing
process occurred (for inspectors and attorneys)
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WHY WRITE SOPs? To Ensure Safety Maximize
operational and production requirements
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WHY WRITE SOPs? To Ensure Consistent
Training To Ensure Correct and Consistent
Performance To Ensure Regulatory Compliance
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WHY WRITE SOPs? To Ensure Consistent
Training To Ensure Correct and Consistent
Performance To Ensure Regulatory
Compliance Just Because It Makes Good Sense
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WHY WRITE SOPs? Because historically many have
not exercised good sense and failed to provide
adequate training and consistency in performance,
product or process failures have resulted in harm
to animals, research subjects and patients.
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WHY WRITE SOPs? The FDA Has Placed Us In An
Environment of Regulatory Compliance!!!!
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WHY WRITE SOPs? Most regulatory and accrediting
agencies require that those who perform
procedures have the education, experience and
training to do so.
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WHY WRITE SOPs? SOPs are the foundation of
training!
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REGULATORY REQUIREMENTS Good Manufacturing
Practice 21 CFR 211.100 There shall be written
procedures for production and process control
designed to assure that the drug products have
the identity, strength, quality, and purity they
purport or are represented to possess.
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REGULATORY REQUIREMENTS Good Laboratory
Practice 21 CFR 58.81(a) A testing facility
shall have standard operating procedures in
writing setting forth nonclinical laboratory
study methods that management is satisfied are
adequate to insure the quality and integrity of
the data generated in the course of a study.
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REGULATORY REQUIREMENTS Good Tissue Practice 21
CFR 1271.180 You must establish and maintain
procedures appropriate to meet core CGTP
requirements for all steps that you perform in
the manufacture of HCT/Ps. You must design these
procedures to prevent circumstances that increase
the risk of the introduction, transmission, or
spread of communicable diseases through the use
of HCT/Ps.
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REGULATORY REQUIREMENTS ICH Guidance For
Industry E6 Good Clinical Practice Consolidated
Guidance Principles of ICH GCP 2.13 Systems
with procedures that assure the quality of every
aspect of the trial should be implemented.
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FOCUS OF FDA INSPECTIONS BIORESEARCH
MONITORING BIMO Compliance Program Guidance
Manual Chapter 45 Biological Drug
Products Inspection of Biological Drug Products
(CBER) 7345.848
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FOCUS OF FDA INSPECTIONS

• Six Key Systems
• Quality System
• Process
• Facilities and Equipment
• Materials
• Packaging and Labeling
• Laboratory Control

• Three Critical Elements
• SOPs
• Training
• Records

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Common Elements GLP GMP GTP QA
Unit Processing SOPs Records Personnel Facilities
Equipment Reagents
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REGULATORY REQUIREMENTS Strive to create a
culture of compliance
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FORMATS FOR SOPs There are almost as many
different formats as there are institutions,
agencies and companies that write them. Pick
One Document It Enforce It You Need and SOP on
SOPs
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AN IMPORTANT POINT An SOP is not a Policy A
policy tells you WHAT you will do, An SOP tells
you HOW you will do it!
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A Policy UAMS ADMINISTRATIVE GUIDE NUMBER
3.1.15DATE 03/05/2002REVISION 08/15/2005 SECTI
ONADMINISTRATION AREAGENERAL ADMINISTRATION
SUBJECT CONFIDENTIALITY POLICY
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A Policy UAMS prohibits the unlawful or
unauthorized access, use or disclosure of
confidential and proprietary information obtained
during the course of employment or other
relationship with UAMS.   As a condition of
employment, continued employment or relationship
with UAMS, UAMS workforce shall be required to
sign the UAMS Confidentiality Agreement approved
by the UAMS Office of General Counsel.  
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A Policy UAMS will provide training for each of
its workforce members on the importance of
maintaining confidentiality and the specific
requirements of state and federal law, including
the HIPAA Privacy Regulations and laws protecting
the privacy of students and employees. This
policy applies to information maintained or
transmitted in any form, including verbally, in
writing, or in any electronic form.
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UAMS Administrative Guide This Administrative
Guide contains sections for Both Policy and
Procedure. It also includes Scope, Purpose and
Forms associated with the procedure.
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SOP FORMATS THREE MAJOR TYPES Standard
List Outlined List Playscript
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WRITING GOOD SOPs Accurate Up to Date Easy
To Understand and Follow Accomplishes the
purpose for which it is written
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SUGGESTED FORMAT PURPOSE SCOPE RESPONSIBILITY REF
ERENCES DEFINITIONS PROCEDURE ATTACHMENTS REVISION
HISTORY
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WHERE TO START Why Is An SOP Needed? Who Is
The Target Audience? Will The SOP Be
Inter-Departmental? Who Will Write The SOP?
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WHERE TO START Just Get Something On
Paper (Writers Block) Use A Flow Chart
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TITLE This must describe in sufficient detail
the focus of the SOP so that anyone can tell from
the title the content of the SOP when searching a
list of SOPs This More Important Than You Think!
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PURPOSE What You Want To Accomplish This often
will duplicate the title of the SOP Title
Writing, Review and Approval of Standard
Operating Procedures The Purpose of this
procedure is to define the process used to write,
review and approve standard operating procedures
of the Quality Assurance Unit or To define the
process used to write, review and approve
standard operating procedures of the Quality
Assurance Unit
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SCOPE The scope defines the area to which the
SOP applies This procedure applies to all
policies and procedures used by the Quality
Assurance Unit
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RESPONSIBILITY This states who has
responsibility for training and execution of the
SOP It is the responsibility of the Quality
Assurance Manager or designee to assure that all
Quality Assurance Specialists are trained on and
comply with this standard operating procedure
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RESPONSIBILITY You may want to include other
statements in the responsibility section as
suggested by your accrediting body. You must
state this in your SOP on SOPs
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REFERENCES List all references that serve as
the basis for the SOP Do not list regulations,
text books, standards, or articles, etc. without
reference to sections or page numbers!
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REFERENCES 4.0 REFERENCES 4.1 ORC SOP 100.01
Policy and Standard Operating Procedure,
Creation, Revision, and Implementation
Standards 4.2 21 CFR 58.35(c) 4.3 21 CFR
211.22(d) 4.4 21 CFR 820.20(a) 4.5 21 CFR
820.20(e) 4.6 21 CFR 1271.160(b)(1) NOT 21
CFR 211
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DEFINITIONS List all definitions that are
essential to an understanding of the SOP
including all acronyms
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DEFINITIONS 5.0 DEFINITIONS 5.1 QAU Quality
Assurance Unit 5.2 CFR Code of Federal
Regulation 5.3 SOP Standard Operating
Procedure 5.4 GMP Good Manufacturing
Practice 5.5 GTP Good Tissue Practice 5.6
Controlled Document A policy, standard
operating procedure, or form. 5.7 Document
For this SOP, any controlled document. 5.8
Manager For this SOP, the Quality
Assurance Unit Manager. 5.9 O drive The
ORC computer network drive.
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SOME GUIDELINES Use words such
as Shall Must Will When more than one person
carries out an activity Do not use Should May
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SOME GUIDELINES Begin each activity with an
active verb such as Analyze Begin Check Delete E
nter Start Store Submit When only one person
carries out an activity
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SOME GUIDELINES Do not begin a step with a
conditional phrase such led by When, After,
If Avoid Jargon and Abbreviations Unless
Defined Avoid Complexity
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PROCEDURE 6.0 Procedure 6.1 Writing a new
document 6.1.1 Any staff member shall submit a
written draft to the QAU Manager for
consideration 6.1.2 The Manager shall
discuss the submitted draft with the
submitting staff member to make any changes
necessary prior to circulating a draft for
review.
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PROCEDURE 6.1.3 The Manager or designee shall
circulate the draft to all appropriate QAU
staff for review and comment. 6.1.4 Each
reviewer shall make changes and comments in
red ink on the draft if necessary, initial and
date any changes, and send the draft to the
next available reviewer. 6.1.5 The last
reviewer shall return the draft to the Manager
for review and comment.
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ATTACHMENTS Any forms, logs or other documents
that are essential to the execution of the SOP
and mentioned in the SOP shall be attached to
the SOP
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ATTACHMENTS 7.0 ATTACHMENTS 7.1 Example
Coversheet Text for Document Approval 7.2 Auth
orized Copy Log Template 7.3 Staff Training
Documentation Record 7.4 Example Annual Review
Coversheet
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REVISION HISTORY This will include a detailed
list of what changed in the revision. It is
extremely important to know what changed and
when (Inspections, Accidents, Attorneys)
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REVISION HISTORY
8.0 Revision History
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QUESTIONS?