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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. WHAT IS AN SOP?. WHY WRITE SOPs?. GOALS

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Presentation Transcript
slide1

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

slide5

GOALS

  • Define what is an SOP
  • State reasons for writing SOPs
  • Describe the different formats for SOPs
  • Describe how to write an SOP
slide7

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

slide8

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

slide9

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

slide10

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

slide11

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

slide12

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)

slide13

WHY WRITE SOPs?

To Ensure Safety

Maximize operational and production requirements

slide14

WHY WRITE SOPs?

To Ensure Consistent Training

To Ensure Correct and Consistent Performance

To Ensure Regulatory Compliance

slide15

WHY WRITE SOPs?

To Ensure Consistent Training

To Ensure Correct and Consistent Performance

To Ensure Regulatory Compliance

Just Because It Makes Good Sense

slide16

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.

slide17

WHY WRITE SOPs?

The FDA Has Placed Us In An Environment of

Regulatory Compliance!!!!

slide18

WHY WRITE SOPs?

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

slide19

WHY WRITE SOPs?

SOPs are the foundation of training!

slide20

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.

slide21

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.

slide22

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.

slide23

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.

slide24

FOCUS OF FDA INSPECTIONS

BIORESEARCH MONITORING

BIMO

Compliance Program Guidance Manual

Chapter 45 – Biological Drug Products

Inspection of Biological Drug Products (CBER)

7345.848

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

FOCUS OF FDA INSPECTIONS
slide26

Common Elements

GLP & GMP & GTP

QA Unit

Processing

SOPs

Records

Personnel

Facilities

Equipment

Reagents

slide27

REGULATORY REQUIREMENTS

Strive to create a culture of compliance

slide28

FORMATS FORSOPs

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

slide29

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!

slide30

A Policy

UAMS ADMINISTRATIVE GUIDE

NUMBER: 3.1.15DATE: 03/05/2002REVISION: 08/15/2005

SECTION:ADMINISTRATION

AREA:GENERAL

ADMINISTRATION SUBJECT:

CONFIDENTIALITY POLICY

slide31

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.  

slide32

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.

slide33

UAMS

Administrative Guide

This Administrative Guide contains sections for

Both Policy and Procedure.

It also includes Scope, Purpose and Forms associated with the procedure.

slide34

SOP FORMATS

THREE MAJOR TYPES

Standard List

Outlined List

Playscript

slide35

WRITING “GOOD” SOPs

Accurate

Up to Date

Easy To Understand and Follow

Accomplishes the purpose for which it is written

slide36

SUGGESTED FORMAT

PURPOSE

SCOPE

RESPONSIBILITY

REFERENCES

DEFINITIONS

PROCEDURE

ATTACHMENTS

REVISION HISTORY

slide41

WHERE TO START

Why Is An SOP Needed?

Who Is The Target Audience?

Will The SOP Be Inter-Departmental?

Who Will Write The SOP?

slide42

WHERE TO START

Just Get Something On Paper

(Writers Block)

Use A Flow Chart

slide43

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!

slide44

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

slide45

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

slide46

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

slide47

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

slide48

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!

slide49

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

slide50

DEFINITIONS

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

slide51

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.

slide52

SOME GUIDELINES

Use words such as:

Shall

Must

Will

When more than one person carries out an activity

Do not use

Should

May

slide53

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

slide54

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

slide55

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.

slide56

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.

slide57

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

slide58

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

slide59

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)

slide60

REVISION HISTORY

8.0 Revision History