A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity followed by an organization.

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2. Contents
1. Introduction
2. Objectives
3. Benefits
4. Types of SOP
5. SOP Writing Style
6. SOP Process
7. SOP General Format
8. Copies of SOP
9. Examples Of SOP’s
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3. Introduction
• A Standard Operating Procedure (SOP) is a set of written instructions that
document a routine or repetitive activity followed by an organization
• ICH defines SOPs as "detailed, written instructions to achieve uniformity of
the performance of a specific function“.
• SOPs aim to achieve efficiency, quality output and uniformity of performance,
while reducing miscommunication and failure to comply with industry
regulations
• Other terms may also be used instead of the term SOP
 Protocols
 Instructions
 Worksheets
 Safe operating procedures
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4. • Backbone of pharmaceutical industry.
• Although each industry or factories have their
own SOPs, the basic concept, structure and
content remain the same.
• SOPs must be reviewed prior to their approval for
release, for adequacy, completeness and
compliance with Company standards and all
applicable legal, ethical and regulatory
requirements.
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5. OBJECTIVES
 To maintain the quality control and quality assurance.
 To plant effectiveness and efficacy.
 To serve as guidelines for the users about the processes.
 To serve as a training document for teaching new users about the process.
 To provide individuals with the information to perform a job properly.
 To facilitate uniformity or consistency in the quality and integrity of a product
or end-result.
 To ensure that processes continue uninterrupted and are completed on a
prescribed schedule.
 To serve as a checklist for auditors.
 To serve as an historical record for the change over.
 To serve as an explanation in review of accident investigation.
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6. • To provide people with all the safety,
health, environmental and functional
information necessitated to perform
a job properly.
• To guarantee that production
operations are performed constantly
to obtain quality control of
processes and products.
• To guarantee that processes
continue uninterrupted and are
completed on a prescribed schedule.
• To guarantee that no failures occur
in manufacturing and other
processes that would harm anyone
in the surrounding community.
BENEFITS
• To guarantee that acknowledged
procedures are followed in
compliance with company and
government regulations.
• To serve as a training document for
teaching users about the process for
which the SOP was written.
• To serve as a checklist for co-
workers who observe job
performance to reinforce proper
performance.
• To serve as an explanation of steps
in a process so they can be reviewed
in accident investigations.
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8. TYPES OF SOPS
Technical SOP Administrative SOP
1. SOPs instructing the
user
 how to perform a
specific analytical
method to be followed
in the laboratory
 how to collect a
sample in order to
preserve the sample
integrity and
representativeness
1. SOPs generated for
administrative tasks
 Reviewing
documentation such
as QA Project Plans
and QMP
 Writing contracts
 Performance
assessment
2. Also cover data
processing and
evaluation (including
verification and
validation), modeling,
risk assessment.
2. Also includes how to
coordinate the activity
and record the results as
well as coordinating the
team efforts.
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9. SOP Writing Style
 SOPs should be written in a concise, step-by-step, easy-to-
read format.
 The information presented should be clear and not overly
complicated.
 The active voice and present verb tense should be used.
 Keep it simple and short.
 Use a flow chart to illustrate the process being described.
 In addition, follow the style guide used by your organization,
e.g. font size and margins.
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10. SOP Process
SOP
Preparation
SOP
Review
and
Approval
Frequency
of
Revisions
and
Reviews
Checklists
&
Document
Control
Management
of SOP
Implement-
-ation of
SOP
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11. Initiation of a new SOP
SOP Preparation
 The organization should have a
procedure in place for determining what
procedures or processes need to be
documented.
 SOPs should be written by an individual
who performs the tasks routinely or
someone who is directly responsible for
the performance of the task.
Draft copy of the SOP
Review by Initiator
Department Head
Review by QA personnel
Review by QA Head/
Designee
Final approval by QA
Head/Designee
QA personnel takes out the
print of final SOP
Corrections
to be done
by initiator
department
NO
YES
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12. SOP Review and Approval
 SOPs should be reviewed by one or more individuals with appropriate training and
experience.
 This process especially helpful if draft SOPs are actually tested by individuals other than
the original writer before the SOPs are finalized.
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13. Frequency of Revisions and Reviews
 SOPs need to remain current to be useful.
 Whenever procedures are changed, SOPs should be updated and re-approved.
 If desired, modify only the relevant specific section of an SOP and indicate the change
date/revision number for that section in the Table of Contents and the document control
notation.
 SOPs should be also systematically reviewed on a periodic basis, e.g. every 1-2 years, to
ensure that the policies and procedures remain current and appropriate, or to determine
whether the SOPs are even needed.
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14. Checklist & Document Control
 Any checklists or forms included as part of an activity should be referenced at the points in
the procedure where they are to be used and then attached to the SOP.
 Generally, each page of an SOP should have control documentation notation.
 A short title and identification (ID) number can serve as a reference designation.
 The revision number and date are very useful in identifying the SOP in use when reviewing
historical data and is critical when the need for evidentiary records is involved and when
the activity is being reviewed.
 When the number of pages is indicated, the use can quickly check if the SOP is complete.
 Generally this type of document control notation is located in the upper right-hand corner
of each document page following the title page.
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15.  The most important step for implementing the SOP is in working area, train or retrain the user.
 Everyone should follow the procedure exactly with each and every step in detail, it is very
important to train the user otherwise individual may interpret meaning in different ways.
 While training the user trainer should share the reason WHY SOP must performed correctly.
 People are much more to follow when they understand importance of procedure.
 Trainer should explain and demonstrate how each step in the SOP will be performed and should
assure them this will increase Quality of product by providing safety and accuracy which will
ultimately increase the confidence of the user.
Implementation of SOP
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16. Management of SOP
• Management of SOP is done by system owner
• Ideally a system owner:
 Eliminates obsolete SOPs. (Which is not needed)
 Ensures that SOPs meet their quality requirements and are user friendly.
 Manages SOP change controls.
 Distributes SOPs.
 Ensures that SOPs are current.
 Ensures that new or changed SOPs are valid only after training has occurred and provides
training about the SOP system.
 Measures system performance and periodically reports results to management.
 Continuously improves the system.
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17. SOP GENERAL FORMAT
• SOPs should be organized to ensure ease and efficiency in use and to be specific to the
organization which develops it.
• It possible break the information into a series of logical steps to avoid a long list.
• SOP generally consists of
 Company name/logo and pagination: Must appear in every page.
 Title Page
 Table of Contents
 Text
 Footer
 Stamp
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18. Title Page:
Activity, SOP ID
number, Revision
number, Issue
date/Revision
date,
Department/Bran
ch, Signature
with date etc.
Table of
contents:
Quick
reference,
Locating
information,
Denote changes
or revision.
Text:
Purpose, Scope,
Responsibilities,
Summery
of the procedure,
References,
Definitions,
Precautions,
Personnel
qualifications,
Safety
considerations,
Documentation,
Materials
and Equipment,
Procedure,
Attachments.
Footer:
Approving
signatures
with date
 Prepared by
 Checked by
 Approved by
Stamp:
 Controlled
Copy/Master
Copy
 QA Stamp, etc
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19. Table of contents
Title Page
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20. Text
Footer
Stamp
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21. Copies of SOP
 Master copy
Original signed copy(kept in QA) .
 Controlled copy
Used at actual working place.
 Uncontrolled copy
For information purpose only.
 Obsolete copy
For obsolete activity.
 Superseded copy
Previous copy which is replaced by new one.
 Approved copy
For regulatory submission.
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22. Examples Of Sop’s
 httpswww.researchgate.netpublication261951679_Standard_Operatin
g_Procedure_SOP_for_Pharmaceutical_Dispensing.pdf
 SOP for Manufacturing of Tablets and Capsules.pdf
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23. References
(1) Akyar, I. Standard Operating Procedures (What Are They Good For ?). In Latest Research into Quality
Control; Akyar, I., Ed.; InTech: London, England, 2012. https://doi.org/10.5772/50439.
(2) Qa/g-, E. Guidance for preparing standard operating procedures (SOPs) https://clu-
in.org/download/toolkit/thirdednew/guidanceprepsops.pdf (accessed Nov 24, 2021).
(3) Guidance for Preparing Standard Operating Procedures (SOPs) https://www.pharmalex.com/standard-
operating-procedures/ (accessed Nov 24, 2021).
(4) Editorial Team. Standard operating procedures (SOP): What, types and how to write?
https://blog.bit.ai/standard-operating-procedures-sop/ (accessed Nov 24, 2021).
(5) Standard operating procedure: Types, writing guidelines, and examples
https://limblecmms.com/blog/standard-operating-procedure-sop/ (accessed Nov 24, 2021).
(6) Pharmainform https://www.pharmainform.com/2020/11/how-to-write-sop.html (accessed Nov 24, 2021).
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24. References
7) Guidance document for the writing of standard operating procedures (Taken from United States
Environmental Protection Agency Guidance for Preparing Standard
https://www.smu.ca/webfiles/SOPGuidanceDocument.pdf (accessed Nov 24, 2021).
8) Deptt. STANDARD OPERATING PROCEDURE https://slideplayer.com/slide/14515429/ (accessed Nov
24, 2021).
9) https://www.researchgate.net/publication/261951679_Standard_Operating_Procedure_SOP_for_Pharmac
eutical_Dispensing (accessed Nov 24, 2021).
10) Two types of standard Operating Procedures: Technical and management
https://www.getmaintainx.com/blog/two-types-of-standard-operating-procedures-technical-and-
management/ (accessed Nov 24, 2021).
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25. THANK
YOU!
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