STANDARD OPERATING

PROCEDURE (SOP)

K.RAM BABU
DY.Manager - QA,
VIVIMED labs, Unit – I,
Bidar.Karnataka.
 What is standard operating
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 SOP
Title : Descriptive
Code : Number relating to procedure and revisions
Objective : Aim of the procedure clearly described
Scope : The operating unit and field of application
Definitions : 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
a standard operating
procedure (SOP)
 Tool to Assure consistency by following
written procedure
 Eliminates interpretational errors
 Used to train employees on procedures
 Makes verification possible through
corresponding
 What should be the contents
of an SOP
Purpose
Scope
Accountability/Responsibility
Procedure
Frequency
Designations of persons(s) who carry out &
supervise the activity
 How do you write a procedure
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
 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
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
 What are the kinds of standard
Operating Procedure ?

 Procedure for control and assurance

 Procedures for preparing protocol
How is compliance of an SOP
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
maintained for compliance
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
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
Procedure

Departmental Head
&
Quality Assurance
 When should a procedure be
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
revised ?
 Ifduring 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