STANDARD OPERATING STANDARD OPERATING PROCEDURE (SOP)PROCEDURE (SOP)

K.RAM BABU DY.Manager - QA,

VIVIMED labs, Unit – I, Bidar.Karnataka.

What is standard operating What is standard operating procedure (SOP)procedure (SOP)

An authorized written procedure giving instructions for performing operations not necessarily 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).

Format of an SOPFormat of an SOPTitle : DescriptiveCode : Number relating to procedure and revisionsObjective : Aim of the procedure clearly describedScope : The operating unit and field of applicationDefinitions : Meaning of principle terms used Description : Operating instructions clearly

described without any ambiguity, understood by all staff with flow diagrams

Safety : Measures to be kept in mind when executing the SOP

Documentation : Protocol, Data sheets and measurements References : Used to draw up the SOP

Why do you require Why do you require a standard operating a standard operating

procedure (SOP)procedure (SOP)

Tool to Assure consistency by following written procedure

Eliminates interpretational errorsUsed to train employees on proceduresMakes verification possible through

corresponding

What should be the contents What should be the contents of an SOP of an SOP

PurposeScopeAccountability/ResponsibilityProcedureFrequencyDesignations of persons(s) who carry out &

supervise the activity

How do you write a procedure How do you write a procedure having the above contents ?having the above contents ?

Purpose : Describes as to why this procedure is required.

Scope : Describes as to the areas / activities encompassed

Accountability : Names a person who remains accountable for implementation

Procedure Procedure

Describes the details how to carry out the activity in a step by step, logical, sequential manner in simple sentences and easy to understand.

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

What are the kinds of standard What are the kinds of standard Operating Procedure ?Operating Procedure ?

Procedures for performing all activities which have a bearing on Quality of Product

Procedures for inwarding, storage and issues of materials

Work Instructions for operating Equipments & Utilities

Work Instructions for manufacturing Procedures for calibration Procedures for maintenance

Procedure for control and assuranceProcedures for preparing protocol

What are the kinds of standard What are the kinds of standard Operating Procedure ?Operating Procedure ?

How is compliance of an SOP How is compliance of an 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

What are the records to be What are the records to be maintained for compliance maintained for compliance

with procedure ?with procedure ? Filled formats Equipment Logs Maintenance Logs Calibration records Test reports List all materials or equipment needed to perform

the procedure wherever found to necessary If any formats have to be maintained during

carrying out the activity, the same has to be attached

Who should prepare the Who should prepare the procedure ? procedure ?

Person who carry out the procedure and or person who supervises the procedure

If another department has a role in implementing the same, QA has to ensure that is Approved by them

Who should scrutinize a Who should scrutinize a Procedure Procedure

Departmental Head &

Quality Assurance

When should a procedure be When should a 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

When should a procedure be When should a procedure be revised ?revised ?

If during the period a change is warranted, the proposer forwards the changes to Quality Assurance with due justification . The person who has to carry out the activity and the person responsible have to be notified and opinion sought and then revised.

QUALITY IS NEVER AN ACCIDENT

IT IS ALWAYS THE RESULT OF INTELLIGENT EFFORT