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Research Support &

Regulatory Affairs

Quality Assurance Unit

WRITING STANDARD

OPERATING PROCEDURES

(SOPs)

When: Wednesday, August 23, 2006

9:00 – 11:00 am

Where: Biomed I – Room 205/207

Raymond C. Anderson, PhD

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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_Operating_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:

Six Key Systems:



Quality System

Quality System



Process

Process



Facilities and

Facilities and

Equipment

Equipment



Materials

Materials



Packaging and

Packaging and

Labeling

Labeling



Laboratory Control

Laboratory Control

Three Critical

Three Critical

Elements:

Elements:



SOPs

SOPs



Training

Training



Records

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: 3.1.15

DATE: 03/05/2002

REVISION: 08/15/2005

SECTION:ADMINISTRATION

AREA:GENERAL

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

REFERENCES
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

Enter

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

Authorized 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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Revisio

Revisio

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Date

Date

Description of Change

Description of Change

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03/31/0

03/31/0

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This is a new procedure

This is a new procedure

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08/23/0

08/23/0

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Changed 6.2 to include micro tubes

Changed 6.2 to include micro tubes

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Corrected spelling of femoral in 6.5

Corrected spelling of femoral in 6.5

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Replace lab technician with lab

Replace lab technician with lab

manager in 6.8

manager in 6.8

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Deleted reference to cell therapy

Deleted reference to cell therapy

8.0 Revision History

REVISION HISTORY

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QUESTIONS?