Standard Operating Procedure

Presented By – Amey Deshpande

Guided BY – R V Kshirsagar
 Overview

• Introduction
• Need of SOP
• Benefits of SOP
• Format and Content of Sop
• Writing Styles
• Sop Process
• Conclusion
1. INTODUCTION
• The ICH defines SOPs as ‘detailed written
instructions to achieve uniformity of the
performance of a specific function’
• An SOP is a set of written instructions that
document a routine or repetitive activity
followed by an organization
• an integral part of a successful quality system
2. Need of SOP
• SOPs document the way activities are to be
performed to facilitate consistent conformance
and to support data quality
• SOPs Describe fundamental programmatic
actions and technical actions (such as analytical
processes) and processes for maintaining,
calibrating and using equipment.
2. Need of SOP (….continued…)
• SOP help to complete various tasks more reliably
and consistently
•SOP clears ideas of an individual about………
What is the objective of SOP (Purpose)
What are applicability and use of SOP (Scope)
Who will perform tasks (Responsibility)
Who will ensure implementation of procedure
(Accountability)
How tasks will be performed (Procedure)
 3. Benefits Of Sop
1.To provide the safety, health, environmental and
operational information necessary to perform a job
properly
2.To ensure that production operations are performed
consistently to maintain quality control of processes
and products
3.To ensure that processes continue uninterrupted and
are completed on a prescribed schedule
4.To ensure that approved procedures are followed in
compliance with company and government
regulations
cont………
 3. Benefits Of SOP (….cont…)
6.To serve as a training document for teaching
users about the process for which the SOP was
written
7.To serve as a checklist for auditors
8.To serve as an historical record of the how, why
and when of steps came in an existing process
so there is a factual basis for revising those
steps when a process or equipment are
changed
9.To serve as an explanation of steps in a process so
they can be reviewed in accident investigations
4. SOP – Writing Styles
• written in a concise, step by step, easy to read
and easy to follow format
• The information presented should be
unambiguous and not complicated
• Use The active voice and present tense
• SOP shall be simple and short
• Information should be clear and explicit to
remove any doubt
• Flow chart shall be used to illustrate the process
being described.
5. Format And Content Of Sop
• number of different ways to organize and format SOPs
• factors which determine what type of SOP to use or
create :

Does SOP
Does SOP
consist of Best format for
Sr. involve many
more than 10 Examples
decisions? writing SOP
No. steps?

Simple sequential SOP for balance

1 No No
steps calibration
Sequential steps
2 No Yes along with Entry / Exit procedure
Pictorial diagrams
Sequential Steps SOP for deviation
3 Yes No / Yes
with Flow chart management
5. Format And Content Of Sop
• There should be Consistent Format for SOP
• Requirement for (i) document identification and
control, (ii) accountability and traceability, (iii)
responsibility must be included with every SOP
• Since there is no FDA approved format for a SOP,
however there are common expectation within
industry and from the FDA that assure
accountability and traceability and consistency of
the documents, when choosing format for a
procedure consider the following
…………[cont…]
5. Format And Content Of Sop
1. Company Name and Pagination
2. Title
3. Identification and control
4. Review and Approval
5. Purpose
6. Scope
7. Responsibility
8. Procedure
9. Checklists
5. Format And Content Of Sop
Company Name and Address: Page No: X of Y
Title : SOP No:
Revision No:
Review Period:
Prepared By Reviewed By Approved By
   

Objective/Purpose
Scope
Responsibility
Procedure
6. Sop Process
1. Sop Preparation
2. SOP Review and Approval
3. Frequency of Revisions and Reviews
4. Checklists
5. Document Control
6. SOP Document Tracking and Archival
7. Implementing SOP
8. Management of SOP
6. Sop Process
1. Sop Preparation
1. Determine procedures to be documented
2. Prepared By –Individuals with knowledge of
activities and internal structure of organization
3. A team approach can be followed, especially
for multi-tasked processes
6. Sop Process
2. SOP Review and Approval
1. Reviewed (that is, validated) by one or more
individuals with appropriate training and
experience with the process
2. Immediate supervisor (section or branch chief or
quality assurance officer) review and approve
each SOP
3. Signature approval indicates that an SOP has
been both reviewed and approved by
management
6. Sop Process
3. Frequency of Revisions and Reviews
1. SOPs need to remain current to be useful
whenever procedures are changed, SOPs
should be updated and re-approved
2. Systematically review SOPs on a periodic
basis, e.g. every 1-2 years
3. The review date should be added to each
SOP that has been reviewed
6. Sop Process
4. Checklists
1. To ensure that steps are followed in order and to
document completed actions
2. Any checklists or forms should be referenced at the
points in the procedure where they are to be used
and then attached to the SOP
3. Copies of specific checklists should be maintained in
the file with the activity results and/or with the SOP
4. Remember that the checklist is not the SOP, but a
part of the SOP
6. Sop Process
5. Document Control
1. Each organization should develop a system to
systematically identify and label their SOPs
2. Each page of an SOP should have control
documentation notation, a short title and
identification number
3. When the number of pages is indicated, the
user can quickly check if the SOP is complete
6. Sop Process
6. SOP Document Tracking and Archival
1. The organization should maintain a master list of
all SOPs indicating the SOP number, version
number, date of issue, title, author, status,
organizational division, branch, section, and any
historical information regarding past versions
2. The QA Manager responsible for maintaining
such files
3. This file or list may be also used during audits
4. Electronic storage and retrieval mechanisms are
usually easier to access than a hard-copy
document format.
6. Sop Process
7. Implementing SOP
1. Everyone should follow the procedure exactly with each
and every step in detail
2. it is very important to train the user otherwise individual
may interpret meaning indifferent ways.
3. While training the user, trainer should share the reason
why SOP must performed correctly
4. Trainer should explain and demonstrate how each step
in the SOP will be performed and should assure them
this will increase Quality of product, provide safety and
accuracy  increase the confidence of the user.
6. Sop Process
8. Management of SOP
1. Organization shall have SOP on Preparation, approval, revision
and control of standard Operating Procedure for better
control and management of SOPs.
2. Ideally, there should be a system owner who
• Eliminates obsolete SOPs.
• 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.
 7. Conclusion
• SOPs serve as a fundamental means of communication
for all levels of the organization
• Not only do they involve employees departmentally, but
they also allow management and employees to gain a
cross-functional view of the organization
• This approach encourages employees to think about how
process change may affect other functional areas
• A good system forces Employee to think through
processes and examine how Procedure might affect
product, personnel, production, and equipment
• It shall be noted that the best written SOPs will fail if
they are not followed