writing sop

*Research Support &Regulatory AffairsQuality Assurance UnitWRITING STANDARDOPERATING PROCEDURES(SOPs)When: Wednesday, August 23, 2006 9:00 11:00 amWhere: Biomed I Room 205/207Raymond C. Anderson, PhD

*WHAT IS AN SOP?

*WHY WRITE SOPs?

*GOALS

Define what is an SOPState reasons for writing SOPsDescribe the different formats for SOPsDescribe 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, PhDDepartment of Journalism and CommunicationLehigh University, Bethlehem, PA

*WHAT IS AN SOP?

An SOP is a set of written instructions that document a routine or repetitive activity.

EPA Quality SystemFrequent Questions StandardOperating 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

*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

*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)

*WHY WRITE SOPs?

To Ensure Safety

Maximize operational and production requirements

*WHY WRITE SOPs?

To Ensure Consistent Training

To Ensure Correct and Consistent Performance

To Ensure Regulatory Compliance

*WHY WRITE SOPs?

To Ensure Consistent Training

To Ensure Correct and Consistent Performance

To Ensure Regulatory Compliance

Just Because It Makes Good Sense

*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.

*WHY WRITE SOPs?

The FDA Has Placed Us In An Environment of

Regulatory Compliance!!!!

*WHY WRITE SOPs?

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

*WHY WRITE SOPs?

SOPs are the foundation of training!

*REGULATORY REQUIREMENTS

Good Manufacturing Practice21 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.


Good Laboratory Practice21 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.


Good Tissue Practice21 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.


ICH Guidance For IndustryE6 Good Clinical Practice: Consolidated GuidancePrinciples of ICH GCP 2.13

Systems with procedures that assure the quality of every aspect of the trial should be implemented.

*FOCUS OF FDA INSPECTIONSBIORESEARCH MONITORING

BIMO Compliance Program Guidance ManualChapter 45 Biological Drug Products

Inspection of Biological Drug Products (CBER)7345.848

*FOCUS OF FDA INSPECTIONSSix Key Systems:Quality SystemProcess Facilities and EquipmentMaterialsPackaging and LabelingLaboratory ControlThree Critical Elements:SOPsTrainingRecords

*Common Elements

GLP & GMP & GTP

QA UnitProcessingSOPsRecordsPersonnelFacilitiesEquipmentReagents


Strive to create a culture of compliance

*FORMATS FOR SOPs

There are almost as many different formats as there are institutions, agencies and companies that write them.

Pick OneDocument ItEnforce It

You Need and SOP on SOPs

*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!

*A Policy

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

*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.

*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.

*UAMSAdministrative Guide

This Administrative Guide contains sections for Both Policy and Procedure.

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

*SOP FORMATS

THREE MAJOR TYPES

Standard List

Outlined List

Playscript

*WRITING GOOD SOPs

Accurate

Up to Date

Easy To Understand and Follow

Accomplishes the purpose for which it is written

*SUGGESTED FORMAT

PURPOSESCOPERESPONSIBILITYREFERENCESDEFINITIONSPROCEDUREATTACHMENTSREVISION HISTORY

*WHERE TO START

Why Is An SOP Needed?

Who Is The Target Audience?

Will The SOP Be Inter-Departmental?

Who Will Write The SOP?

*WHERE TO START

Just Get Something On Paper(Writers Block)

Use A Flow Chart

*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!

*PURPOSEWhat 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 UnitorTo define the process used to write, review and approve standard operating procedures of the Quality Assurance Unit

*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

*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

*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

*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!

*REFERENCES

4.0REFERENCES

4.1ORC SOP 100.01 Policy and Standard Operating Procedure, Creation, Revision, and Implementation Standards4.221 CFR 58.35(c)4.321 CFR 211.22(d)4.421 CFR 820.20(a)4.521 CFR 820.20(e)4.621 CFR 1271.160(b)(1)

NOT 21 CFR 211

*DEFINITIONS

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

*DEFINITIONS

5.0DEFINITIONS5.1 QAU Quality Assurance Unit5.2 CFR Code of Federal Regulation5.3 SOP Standard Operating Procedure5.4 GMP Good Manufacturing Practice5.5 GTP Good Tissue Practice5.6 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.

*SOME GUIDELINES

Use words such as:

ShallMustWill

When more than one person carries out an activity

Do not use

ShouldMay

*SOME GUIDELINES

Begin each activity with an active verb such as:

AnalyzeBeginCheckDeleteEnterStartStoreSubmit

When only one person carries out an activity

*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

*PROCEDURE

6.0 Procedure6.1 Writing a new document6.1.1 Any staff member shall submit a written draft to the QAU Manager for consideration6.1.2 The Manager shall discuss the submitted draft with the submitting staff member to make any changes necessary prior to circulating a draft for review.

*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.

*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

*ATTACHMENTS

7.0 ATTACHMENTS7.1 Example Coversheet Text for Document Approval7.2Authorized Copy Log Template7.3Staff Training Documentation Record7.4Example Annual Review Coversheet

*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)

*8.0 Revision HistoryREVISION HISTORY

RevisionDateDescription of Change003/31/06This is a new procedure108/23/06Changed 6.2 to include micro tubesCorrected spelling of femoral in 6.5Replace lab technician with lab manager in 6.8Deleted reference to cell therapy

*QUESTIONS?

writing sop

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