sop ppt by zala

8/3/2019 SOP PPT BY ZALA

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STANDARD OPERATINGSTANDARD OPERATING

PROCEDURE (SOP)PROCEDURE (SOP)

Dolatsinh Zala


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What is standard operatingWhat is standard operating

procedure (SOP)procedure (SOP)

An authorized written procedure giving

instructions for performing operations notnecessarily specific to a given process,

product or material (e.g. equipment

operation, maintenance and cleaning;validation; cleaning of premises and

environmental control; sampling and

inspection).


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Format ofan SOPFormat ofan SOP

Title:

DescriptiveCode : Number relating to procedure and revisions

SOP No : SOP /VBCH/IC/ 001 Rev No :

Objective : Aim of the procedure clearly described

Scope : The operating unit and field of applicationDefinitions : Meaning of principle terms used

Description : Operating instructions clearlydescribed without any ambiguity,

understood by all staff with flow diagramsSafety : Measures to be kept in mind when

executing the SOP

References : Used to draw up the SOP

Documentation : Protocol, Formats ( annexures)


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Whydo yourequireWhydo yourequire

a standard operatinga standard operatingprocedure (SOP)procedure (SOP)

Tool to Assure consistency by followingwritten procedure ( eg Dominos Pizza)

Eliminates interpretational errors

Used to train employees on procedures

Makes verification possible through

corresponding

Minimise individual variations /

Mono olies


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What should be the contentsWhat should be the contents

ofan SOPofan SOP

Objective

ScopeAccountability/Responsibility

Procedure

AbbreviationReferences

Annexure


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How do you write a procedureHow do you write a procedure

havingthe above contents ?havingthe above contents ? Objective : Describes as to why this

procedure is required.

Scope : Describes as to the areas / activitiesencompassed

Responsibility : Name of persons who

remains responsible for implimentation Accountability : Names a person who

remains accountable for implementation


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ProcedureProcedure

Describes the details how to carry out the

activity in a step by step, logical, sequential

manner in simple sentences and easy tounderstand.

All steps have to start with action verbs.If it

is required to relate to any other activity,reference to the SOP should be indicted


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Whatare the kinds of standardWhatare the kinds of standard

Operating Procedure ?Operating Procedure ? Procedures for performing all activities which

have a bearing on Quality of Product

Procedures for in warding, storage and issues ofmaterials

Work Instructions for operating Equipments &Utilities

Work Instructions for manufacturing/ services Procedures for calibration

Procedures for maintenance


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Procedure for control and assurance

Procedures for preparing protocol

Whatare the kinds of standardWhatare the kinds of standardOperating Procedure ?Operating Procedure ?


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How is compliance ofan SOPHow is compliance ofan SOP

verified ?verified ? Evaluation through questionnaire

Internal auditing / Verification of Actual

Performance

Verification of Documents prepared in compliance

Quality compliance of intermediate / finished

product and meeting yields norms On the job evaluation by front line supervisors

Reduction trend in rejection of product


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Whatare the records to beWhatare the records to be

maintained forcompliancemaintained forcompliancewith procedure ?with procedure ? Filled formats

Equipment Logs

Maintenance Logs

Calibration records

Test reports

List all materials or equipment needed to performthe procedure wherever found to necessary

If any formats have to be maintained duringcarrying out the activity, the same has to be

attached


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Who should prepare theWho should prepare theprocedure ?procedure ?

Person who carry out the procedure and orperson who supervises the procedure

If another department has a role in

implementing the same, QA has to ensurethat is Approved by them


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Who should scrutinize aWho should scrutinize a

ProcedureProcedure

Departmental Head&

Quality Assurance


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When shoulda procedure beWhen shoulda procedure be

revised ?revised ? These are generally reviewed once a year or

earlier depending on contingencies.

On or before review date Change in the regulatory requirement

Deviations at regular intervals of time

Industry perception in cGMP

Changes in customer expectations

Tightening of controls

Changes in the processing and testing


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When shoulda procedure beWhen shoulda procedure be

revised ?revised ?

If during the period a change is warranted,the proposer forwards the changes toQuality Assurance with due justification .The person who has to carry out the activity

and the person responsible have to benotified and opinion sought and thenrevised.


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QUALITY IS NEVER

AN ACCIDENTIT IS ALWAYS THE RESULT

OF INTELLIGENT EFFORT


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