Get documents about "Format Writing Safety Audit Checklist
Description
Format Writing Safety Audit Checklist document sample
Document Sample
RESEARCH SOPs
AND
COMMON AUDIT FINDINGS
Raymond C. Anderson, PhD
Wednesday, October 11, 2006
9:00 – 9:50 am
Research Support &
Regulatory Affairs
Quality Assurance Unit
1
WHAT IS AN SOP?
2
WHY WRITE SOPs?
3
4
GOALS
• Define an SOP
• Reasons for writing SOPs
• Different formats for SOPs
• Tips for writing an SOP
• List Common Audit Findings
5
WHAT IS AN SOP?
6
WHAT IS AN SOP?
SOPs: Detailed written instructions to
achieve uniformity of performance of a
specific function.
ICH E6 Good Clinical Practice: Consolidated Guidance
7
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
8
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)
9
WHY WRITE SOPs?
To Ensure Safety
Maximize operational and production requirements
10
WHY WRITE SOPs?
To Ensure Consistent Training
To Ensure Correct and Consistent Performance
To Ensure Regulatory Compliance
Just Because It Makes Good Sense
11
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.
12
WHY WRITE SOPs?
As a Result
The FDA Has Placed Academia and Industry
In An Environment of
Regulatory Oversight!!!!
13
REGULATORY BASIS
ICH Guidance For Industry
E6 Good Clinical Practice: Consolidated Guidance
Principles of ICH GCP § 5.13.1
The sponsor should ensure that the investigational
product(s) (including active comparator(s) and
placebo, if applicable) is characterized as appropriate
to the stage of development of the product(s), is
manufactured in accordance with any applicable
GMP…
14
REGULATORY BASIS
“The Commissioner finds that, as stated in 211.1,
these CGMP regulations apply to the preparation of
any drug product for administration to humans or
animals, including those still in investigational
stages.” [Response to comment #49, Preamble
1978 CGMP rule]
15
REGULATORY BASIS
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.
16
REGULATORY BASIS
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.
17
REGULATORY BASIS
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.
18
REGULATORY BASIS
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.
19
FOCUS OF FDA INSPECTIONS
BIORESEARCH MONITORING
BIMO
Compliance Program Guidance Manual
Chapter 45 – Biological Drug Products
Inspection of Biological Drug Products (CBER)
7345.848
20
FOCUS OF FDA INSPECTIONS
Six Key Systems: Three Critical Elements:
Quality System SOPs
Process Training
Facilities and Records
Equipment
Materials
Packaging and
Labeling
Laboratory Control
21
THE GOAL
Strive to create a culture of compliance
22
WHY WRITE SOPs?
Most regulatory and accrediting agencies require that
those who perform procedures have the education,
experience and training to do so.
23
WHY WRITE SOPs?
SOPs are the foundation of training!
24
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 an SOP on SOPs
25
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!
26
SOP FORMATS
THREE MAJOR TYPES
Standard List
Outlined List
Playscript
27
WRITING “GOOD” SOPs
Accurate
Up to Date
Easy to Understand and Follow
Accomplishes the Purpose for Which It Is Written
28
SUGGESTED FORMAT
PURPOSE
SCOPE
RESPONSIBILITY
REFERENCES
DEFINITIONS
PROCEDURE
ATTACHMENTS
REVISION HISTORY
29
30
31
32
33
34
TIPS
WHERE TO START
Why Is An SOP Needed?
Who Is The Target Audience?
Will The SOP Be Inter-Departmental?
Who Will Write The SOP?
35
TIPS
WHERE TO START
Just Get Something On Paper
(Avoid Writer’s Block)
Use A Flow Chart
36
TIPS
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!
37
TIPS
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!
38
REFERENCES
4.0 REFERENCES
4.1 RSRA 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
39
TIPS
DEFINITIONS
List all definitions that are essential to an
understanding of the SOP including all acronyms
40
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 RSRA computer network drive. 41
TIPS
PROCEDURE
Use words such as:
Shall
Must
Will
Do not use
Should
May
(Implies the task is optional) 42
TIPS
PROCEDURE
Begin each activity with an active verb such as:
Analyze
Begin
Check
Delete
Enter
Start
Store
Submit
43
TIPS
PROCEDURE
Do not begin a step with a conditional phrase led by
When, After, If
Avoid Jargon and Abbreviations Unless Defined
Avoid Complexity
44
TIPS
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
(Unless there is another way to control these documents)
45
TIPS
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)
46
REVISION HISTORY
8.0 Revision History
Revision Date Description of Change
0 03/31/06 This is a new procedure
1 08/23/06 1. Changed 6.2 to include micro tubes
2. Corrected spelling of femoral in 6.5
3. Replace lab technician with lab manager in
6.8
4. Deleted reference to cell therapy
47
COMMON AUDIT FINDINGS
Standard Operating Procedures
• Lack of SOPs Where Needed
• Failure To Follow SOPs
48
COMMON AUDIT FINDINGS
Records
• Failure To Maintain Records That Are Accurate,
Indelible, and Legible
• Records Fail To Identify The Person Performing
The Work or The Date The Work Was Done
49
COMMON AUDIT FINDINGS
Quality System
• Failure To Establish and Maintain a Quality
System For Appropriate Monitoring Systems
50
COMMON AUDIT FINDINGS
Training and Education
• Failure To Document Training and Education
51
QUESTIONS?
52
