7. 77
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
8. 88
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
9. 99
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
10. 1010
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
11. 1111
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
12. 1212
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)
14. 1414
WHY WRITE SOPs?
To Ensure Consistent Training
To Ensure Correct and Consistent Performance
To Ensure Regulatory Compliance
15. 1515
WHY WRITE SOPs?
To Ensure Consistent Training
To Ensure Correct and Consistent Performance
To Ensure Regulatory Compliance
Just Because It Makes Good Sense
16. 1616
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.
18. 1818
WHY WRITE SOPs?
Most regulatory and accrediting agencies require that
those who perform procedures have the education,
experience and training to do so.
20. 2020
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.
21. 2121
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.
22. 2222
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.
23. 2323
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.
24. 2424
FOCUS OF FDA INSPECTIONS
BIORESEARCH MONITORING
BIMO
Compliance Program Guidance Manual
Chapter 45 – Biological Drug Products
Inspection of Biological Drug Products (CBER)
7345.848
25. 2525
FOCUS OF FDA INSPECTIONS
Six Key Systems:Six Key Systems:
Quality SystemQuality System
ProcessProcess
Facilities andFacilities and
EquipmentEquipment
MaterialsMaterials
Packaging andPackaging and
LabelingLabeling
Laboratory ControlLaboratory Control
Three Critical Elements:Three Critical Elements:
SOPsSOPs
TrainingTraining
RecordsRecords
26. 2626
Common Elements
GLP & GMP & GTP
QA Unit
Processing
SOPs
Records
Personnel
Facilities
Equipment
Reagents
28. 2828
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
29. 2929
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!
31. 3131
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.
32. 3232
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.
43. 4343
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!
44. 4444
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
45. 4545
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
46. 4646
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
47. 4747
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
48. 4848
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!
51. 5151
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.
52. 5252
SOME GUIDELINES
Use words such as:
Shall
Must
Will
When more than one person carries out an activity
Do not use
Should
May
53. 5353
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
54. 5454
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
55. 5555
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.
56. 5656
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.
57. 5757
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
58. 5858
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
59. 5959
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)
60. 6060
RevisionRevision DateDate Description of ChangeDescription of Change
00 03/31/0603/31/06 This is a new procedureThis is a new procedure
11 08/23/0608/23/06 1.1. Changed 6.2 to include micro tubesChanged 6.2 to include micro tubes
2.2. Corrected spelling of femoral in 6.5Corrected spelling of femoral in 6.5
3.3. Replace lab technician with lab manager inReplace lab technician with lab manager in
6.86.8
4.4. Deleted reference to cell therapyDeleted reference to cell therapy
8.0 Revision History
REVISION HISTORY
