Stanard Operating Procedures

8/10/2019 Stanard Operating Procedures

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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 adirective, 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 regulatorycompliance standards), and in a way that maximizes operational and productionrequirements.

Kenneth A. Friedman, PhDDepartment 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 SystemFrequent Questions StandardOperating 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 aspecific 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 inaccident 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 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 provideadequate 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 performprocedures 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 REQUIREMENTSGood Manufacturing Practice

21 CFR 211.100

There shall be written procedures for production and process control designed toassure that the drug products have the identity, strength, quality, and purity theypurport or are represented to possess.


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REGULATORY REQUIREMENTSGood Laboratory Practice

21 CFR 58.81(a)

A testing facility shall have standard operating procedures in writing setting forthnonclinical 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 REQUIREMENTSGood Tissue Practice

21 CFR 1271.180

You must establish and maintain procedures appropriate to meet core CGTPrequirements for all steps that you perform in the manufacture of HCT/Ps. You

must design these procedures to prevent circumstances that increase the risk ofthe introduction, transmission, or spread of communicable diseases through the

use of HCT/Ps.


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REGULATORY REQUIREMENTSICH Guidance For Industry

E6 Good Clinical Practice: Consolidated GuidancePrinciples of ICH GCP 2.13

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


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FORMATS FOR SOPs

There are almost as many different formats asthere are institutions, agencies and

companies that write them.

Pick OneDocument 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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WRITING

GOOD

SOPs

Accurate

Up to Date

Easy To Understand and Follow

Accomplishes the purpose for which it is written


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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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