WRITING STANDARD

OPERATING PROCEDURES
(SOPs)
Raymond C. Anderson, PhD
When: Wednesday, August 23, 2006
9:00 11:00 am
Where: Biomed I Room 205/207
Research Support &
Regulatory Affairs
Quality Assurance Unit
1

WHAT IS AN SOP?

WHY WRITE SOPs?

GOALS

Define what is an SOP

State reasons for writing SOPs
Describe the different formats for SOPs
Describe how to write an SOP

WHAT IS AN SOP?

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_Operating_Procedures

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

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

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

10

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

11

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)

12

WHY WRITE SOPs?

To Ensure Safety
Maximize operational and production requirements

13

WHY WRITE SOPs?

To Ensure Consistent Training
To Ensure Correct and Consistent Performance
To Ensure Regulatory Compliance

14

WHY WRITE SOPs?

To Ensure Consistent Training
To Ensure Correct and Consistent Performance
To Ensure Regulatory Compliance
Just Because It Makes Good Sense

15

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.

16

WHY WRITE SOPs?

The FDA Has Placed Us In An Environment of

Regulatory Compliance!!!!

17

WHY WRITE SOPs?

Most regulatory and accrediting agencies require that
those who perform procedures have the education,
experience and training to do so.

18

WHY WRITE SOPs?

SOPs are the foundation of training!

19

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.

20

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.

21

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.
22

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.

23

FOCUS OF FDA INSPECTIONS

BIORESEARCH MONITORING
BIMO
Compliance Program Guidance Manual
Chapter 45 Biological Drug Products
Inspection of Biological Drug Products (CBER)
7345.848

24

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

25

Common Elements
GLP & GMP & GTP
QA Unit
Processing
SOPs
Records
Personnel
Facilities
Equipment
Reagents
26

REGULATORY REQUIREMENTS
Strive to create a culture of compliance

27

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
28

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!

29

A Policy
UAMS ADMINISTRATIVE GUIDE
NUMBER: 3.1.15
DATE: 03/05/2002
REVISION: 08/15/2005
SECTION:ADMINISTRATION
AREA:GENERAL
ADMINISTRATION SUBJECT:
CONFIDENTIALITY POLICY

30

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.

31

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.

32

UAMS
Administrative Guide
This Administrative Guide contains sections for
Both Policy and Procedure.
It also includes Scope, Purpose and Forms
associated with the procedure.

33

SOP FORMATS
THREE MAJOR TYPES
Standard List
Outlined List
Playscript

34

WRITING GOOD SOPs

Accurate
Up to Date
Easy To Understand and Follow
Accomplishes the purpose for which it is written

35

SUGGESTED FORMAT
PURPOSE
SCOPE
RESPONSIBILITY
REFERENCES
DEFINITIONS
PROCEDURE
ATTACHMENTS
REVISION HISTORY

36

37

38

39

40

WHERE TO START
Why Is An SOP Needed?
Who Is The Target Audience?
Will The SOP Be Inter-Departmental?
Who Will Write The SOP?

41

WHERE TO START
Just Get Something On Paper
(Writers Block)
Use A Flow Chart

42

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!

43

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
44

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

45

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

46

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

47

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!

48

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
49

DEFINITIONS
List all definitions that are essential to an
understanding of the SOP including all acronyms

50

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.

51

SOME GUIDELINES
Use words such as:
Shall
Must
Will
When more than one person carries out an activity
Do not use
Should
May

52

SOME GUIDELINES
Begin each activity with an active verb such as:
Analyze
Begin
Check
Delete
Enter
Start
Store
Submit
When only one person carries out an activity

53

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

54

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.
55

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.

56

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

57

ATTACHMENTS
7.0 ATTACHMENTS
7.1
Example Coversheet Text for Document
Approval
7.2
Authorized Copy Log Template
7.3
Staff Training Documentation Record
7.4
Example Annual Review Coversheet

58

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)

59

REVISION HISTORY
8.0 Revision History
Revision Date

Description of Change

03/31/06 This is a new procedure

08/23/06

1.
2.
3.
4.

Changed 6.2 to include micro tubes

Corrected spelling of femoral in 6.5
Replace lab technician with lab manager in
6.8
Deleted reference to cell therapy

60

QUESTIONS?

61