Standard Operating Procedures[1]

8/3/2019 Standard Operating Procedures[1]

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(SOP)


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DEFINATION

yA SOP is a set of written instructions that document aroutine or repetitive activity which is followed by an

employee in an organization.y It provides information to perform a job properly , and

consistently in order to achieve pre-determinedspecifications and quality end result.


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NEED OF SOPy SOPs detail the regularly recurring work process

y It document the way the activities are to be performed.

y It describes the fundamental programmatic actionsand technical action

such as :

analytical process and process for maintaining ,

calibrating , & using equipments.

y SOP must contain step by step instructions thatemploy must refer in daily work .


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SOP make clear about following:

PURPOSE(objective of SOP)

SCOPE

(applicability & use of SOP)

RESPONSIBILITY(who will perform the task)

ACCOUNTABILITY

(who will insure implementation of procedure)

PROCEDURE(how the task will be performed)


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BENEFITS OF SOP:1. To provide people with all safety , health ,

environmental & operational information necessaryto perform a job properly.

2. To ensure that production operation are performedconsistently to maintain quality control of process &product.

3. To insure that process continue uninterrupted & are

completed on a prescribed schedule.4. To ensure that no failure occurs in manufacturing &

other processes that would harm anyone I thesurrounding community.


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5. To ensure that approved procedure are followed incompliance with company & government regulation.

6. To serve as a training document for teaching usersabout the process for which SOP was written.

7. To serve as a check list for co-workers who observejob performance to reinforce proper performance.

8. To serve as a check list for auditors.9. To serve as an historical record

10. To serve as an explanation of steps in a process


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SOP WRITING STYLE:y It is written in a concise , step by step , easy to read and

follow format.

y Information presented should be unambiguous andnot complicated.

y The active voice & present verb tense should be used.

y Should be simple & short.

y Flow chart should be used to illustrate the processbeing described.


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FORMATE & CONTENT OF SOPy Company s name & pagination

y Title

y Identification & controly Review & approval

y Purpose

y Scope

y Responsibility

y Procedure

y Checklist


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SOP PREPARATIONy SOPs should be written by an individual

knowledgeable with the activities & organization's

internal structure.yA team approach can be followed for better results.

y Ideally SOPs should be written by team that includesome or all of the following people:

a. Those who will perform the job.b. Those who will perform maintenance on equipment

involved in an SOP.


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c. Engineers or other who design equipment &processes.

d. Technical engineerse. Safety personnel

f. Environmental personnel

g. Equipment manufacturers


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PRECAUTIONS FOR PREPARING SOP

y Instructions & procedure should be written in clearlanguage

yRecords are made in such a way that duringmanufacturing process it will show all the stepsrequired by the defined procedures & instruction havein fact been taken & the quality & quantity of the

product is as excepted.yAny significant deviations are fully recorded &

investigated.


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PROCEDURE FOR PREPARING A SOP

y Document required are to be designed , prepared ,reviewed & distributed with care.

yIt should comply with the relevant part of themanufacturing & operating procedures as well asfacilities available.

y Documents should be approved , signed & dated by

appropriate authorized person & person nominated bythe management.


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PERSONS HAVING AUTHORIZATION

I. Nominee of local staff , expert in their own field &familiar with GMP.

II. General manager (production)III. General manager (QC)

IV. General manager (QA)

V. Nominee of management (may be technical

director)


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FEW IDEAS WHILE WRITING SOP

y The SOP should contain all the safety , health &environmental operations which should give a

complete picture of all the responsibilities for doing ajob properly.

y SOP should satisfy the definition of SOP. It shouldcontain all the steps that are required for an individual

to understand his job.y SOP should not contain more than 10 steps as people

tend to ignore long SOP.


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1. Break the long SOPs into logical sub-job SOPs

2. The shortened SOPs should include only steps & not

the detailed explanationsy Write SOPs for people who perform under different

interpersonal circumstances

1. Write SOP for people who work alone

2. Write SOP for 2 or more people who work together asa team

3. Write SOP for people who will supervise otherpeople doing a job


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4. Write SOP for people who are not familiar with rules

y Consider the age , education , knowledge , skill,

experience , training & work culture of theindividuals who will perform the SOPs steps

y SOPs should include the steps which requirecaution , precision , timing , assistance & personal

protective equipmenty Review the effectiveness of SOP after a few weeks &

make necessary changes


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y Review the SOP when process & equipments arechanged


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SOP REVIEW AND APPROVAL

y SOPs should be reviewed by one or more individualwith appropriate training & experience

y

SOPs should be systematically revised every1-2 years

The reviewed date should be added to each SOP thathas been revised.


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FDA AUDIT FINDING

y Code of federal regulation for drug productmanufactures states (subpart F , CRF Part 211.100 )

there shall be written procedures & process controldesigned to assure the drug product have the identity ,strength , quality , & purity , they purport orrepresented to process .

y

The code of federal regulation for medical devicemanufacturers & other related regulated entities (Title21,CRF Part 820) states repeatedly that firms must


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establish & maintain procedures.

y To do so , companies should define , document (either

on paper or electronically) , & implement SOPs .yAdditionally , companies must then follow up , review

& revise these documents as needed.


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CONCLUSION

y SOPs serve as a fundamental means of communicationfor all levels of the organization.

y

Not only it involve employees departmentally , butthey also allow management & employee to gain across functional view of the organization .

y This approach encourages employees to think about

how process change may affect other functional areas.y Thus , it shall be noted that the best written SOPs will

fail if they are not followed.


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