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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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