2. This presentation is
compiled from freely
available resources like the
website of FDA, WHO,
MHRA and other free
websites
3. 3
WRITING SOPS: INTRO
• Writing SOPs is not an easy
process
Very time-consuming
Involves analysis of your
processes
• pays big dividends when
complete
4. 4
EXPECTED OR DEFINED OUTCOME(S)
Instructions
Protocols
Work Lists
Lab operating procedures (LOPs)
SOP
5. 5
WITH A GOOD PROCEDURE
Staff perform
better
Tasks are
done correctly
Tasks on time
Performed the
same way
and every
time
6. 1. Identify key elements of the operation.
2. Identify authors.
3. Are there experts who know the procedures well?
4. Controls needed?
5. Verify regulations and compliance requirements
6
ORGANIZING YOUR SOP
WRITING EFFORT
7. ORGANIZING YOUR SOP
WRITING EFFORT
6. Know the expected outcomes.
7. Hardware, software, materials and equipment?
8. Forms or other documentation involved?
9. Be attentive of other SOPs that should be
referenced.
7
8. 8
WRITING STYLES
• SOP should be written in a concise, step-by-
step, easy-to-read format.
• The information presented should be
unambiguous and not overly complicated.
• The active voice and present verb tense
should be used.
• The term ”you” should not be used but
implied.
9. WRITING STYLES
9
• The document should not be wordy,
redundant or overly lengthy.
• Keep it simple and short.
• Information should be conveyed clearly and
explicitly to remove any doubts as to what is
required
• Use a flowchart to illustrate the process
being followed.
• Follow the style guide used by your
organization, e.g., font size and margins
10. • Someone should determine what processes need to
be documented in SOPs.
• SOPs are best authored by knowledgeable staff or
subject-matter experts
• A team approach is OK especially for multi-tasked
processes
• The experience requirement for performing an activity
should be noted in the section on personnel
qualifications.
• Input is highly important from the potential users of
the SOP.
10
TAKE YOUR CUE FROM WITHIN
YOUR DEPARTMENT:
11. 11
BEFORE STARTING YOUR 1ST SOP
…ENVISION THE BIGGER PICTURE
• How are the SOPs going to be laid out, maintained
and managed?
• Estimate the total number of SOPs needed.
• Are baseline policies for instructions, clear?
• Are there related regulatory aspects to consider?
• Who is going to approve the final SOPs?
• Are the authors on the same page with
management?
12. 12
ALSO….
Consider the SOP’s:
•Scale and complexity
•Number of steps involved
•Amount of detail necessary within each step
•Is a decision tree involved?
14. 14
SOP AUTHORSHIP
• Who can help you write parts of SOP, or, the
entire document?
• Identify your staff resource(s).
• Identify help early on.
• Get buy in: 1st author, 2nd author, etc.
▼
Aim for Quality!
15. 15
FIGURE OUT THE LENGTH
Few steps =
Short SOP
Moderate
number of
steps =
Longer SOP
Complicated:
Attach
Flow
diagrams;
Or:
Split SOP
16. 16
FORMATS FOR SOPs
There are almost as many different formats as
There are institutions, agencies and
companies that write them.
Pick One
Document &
Enforce It
You Need an SOP on SOPs
17. 17
WHAT FORMAT SHOULD BE
USED?
• "Just spill your guts to your computer and
don't worry about the format"
• Format can always be added later
• If there is a fool proof template that can be
given - might help ease some of anxiety of
novice author
18. 18
WHAT FORMAT SHOULD BE
USED?
• Easier to edit SOPs with default formatting rather
than a doc that has many extra tabs and returns
added in an attempt to emulate accepted format
• Many new authors - involved in correct formatting -
content suffers
• Don't rely on spell check to find all misspelled words
If you use "fur" instead of "for," spell check will blithely
accept it
Use grammar check with care- not find all goofy little
grammar faux pas that can occur when normal people put
word to page
If a word is changed using the Replace command, be sure
to individually approve each replace. Universal replacement
is quick and easy - sometimes too easy - and produces
fodder for News
19. 19
WHAT TO INCLUDE IN AN
SOP
• Company name and Pagination
• Title - with a descriptive verb that defines the
purpose
• Document reference No. and table of
contents
• Identify the business unit, department,
general and specific points of activity for
whom it is written
• State the purpose of SOP
20. 20
• Write a scope statement - including subjects
that SOP will not cover
• List by category items/ tools required for
following SOP
• Give an overview of the steps in the SOP
that describes the process
• Describe machinery, mechanism, processing
system and major components
WHAT TO INCLUDE IN AN
SOP
21. 21
• Define terms and concepts
• Place safety warnings, caution and notes
prominently
• List and explain the process steps in
sequential order of the performance of the
steps
WHAT TO INCLUDE IN AN
SOP
22. 22
SUGGESTED FORMAT
COMPANY NAME & PAGINATION
PURPOSE
SCOPE
RESPONSIBILITY
REFERENCES
DEFINITIONS
PROCEDURE
ATTACHMENTS
REVISION HISTORY
DISTRIBUTION
23. 23
the HEADER
Indicates that the SOP is a controlled document
•Name of the organization; department or division
•Location or address
•Title
•SOP #
•Version #
•Author (s)
•Reviews (either in header or at the end of the SOP)
24. 24
COMPANY NAME &
PAGINATION
The company name and pagination
(e.g." page 3 of 7”) must appear on every
page of the documents. These procedures
can appear in submission documents;
therefore, it should always be apparent
which company is responsible for the
documents
25. 25
TITLE
This must describe in sufficient detail the
focus of the SOP so that anyone can
tell from the title the content of the
SOP when searching a list of SOPs.
This is More Important Than You Think
26. 26
PURPOSE
What You Want To Accomplish
This often will duplicate the title of the SOP
Title: Writing, Review and Approval of Standard
Operating Procedures
The Purpose of this procedure is to define the process
used to write, review and approve standard
operating procedure of the Quality Assurance Unit
Or
To define the process used to write, review and approve
standard operating procedures of the Quality
Assurance Unit
27. 27
SCOPE
The scope defines the area to which
the SOP applies
This procedure applies to all policies
and procedures used by the Quality
Assurance Unit
28. 28
RESPONSIBILITY
This states who has the responsibility for
training and execution of the SOP
It is the responsibility of the Quality
Assurance Manager or designee to assure
that all Quality Assurance Specialists are
trained on and comply with this standard
operating procedure
29. 29
REFERENCES
List all references that serve as the basis
for the SOP
Do not list regulation, text books,
standards, or articles, etc. without
reference to sections or page numbers.
31. 31
DEFINITIONS
Definitions
QAU – Quality Assurance Unit
CFR – Code of Federal Regulation
SOP – Standard Operating Procedure
GMP – Good Manufacturing Practice
Controlled Document – A policy, standard
operating procedure, or form
Document – For this SOP, any controlled
document
32. 32
PROCEDURE
PROCEDURE
1 Writing a new document
1.1 Any staff member shall submit a
written draft to the Head-QA for
consideration.
1.2 Head-QA shall discuss the submitted
draft with the submitting staff member
to make any changes necessary prior
to circulating a draft for review.
33. 33
PROCEDURE
• The Manager or designee shall circulate the draft to
all appropriate staff of the concerned department for
review and comment.
• Each reviewer shall make changes and comments in
red ink on the draft if necessary, initial and date any
changes, and send the draft to the next available
reviewer.
• The last reviewer shall return the draft to the
Manager for review and comment
34. 34
PROCEDURE
SOPs are often sub-divided into types of
procedures. They may be:
Manufacturing Procedures
Quality Test Procedures
Calibration Procedures or
Preventive Maintenance Procedures
with specific format and design requirements
35. 35
PROCEDURE
• Categorization of procedures is useful, but it is best to
categorize them based on the types of activity they
describe.
• Focus on the directive language in the title of procedures (e.g."
Testing of…..”, “Operation of …..”, “Maintenance of…”
• The categorization affords a more specific format for each type
of procedure.
• Categorization also facilitates a more appropriate review and
approval process for the document and could minimize the
review and/or approval signatures and emphasize expert
review.
36. 36
SOP Review and Approval
• Review period for master document is generally 2/3 years
• SOP review will focus on the document’s content, context,
format and grammar.
• Review factors and criteria are:
- Adherence to standards
- Consistency and traceability
- Readability, comprehensibility and general understandability.
- Technical adequacy and feasibility approach.
- Degree of completeness.
- Testability requirements.
- Use of appropriate requirements, design or coding techniques.
- Appropriate level of details.
37. 37
SOME GUIDELINES
Use word such as;
Shall
Must
Will
When more than one person carries out an activity
Do not use
Should
May
38. 38
Begin each activity with an active verb such as
Analyze
Begin
Check
Delete
Enter
Start
Store
Submit
When only one person carries out an activity
SOME GUIDELINES
39. 39
Do not begin a step with a conditional
phrase such as led by, When, After, If
Avoid jargon and Abbreviations Unless
Defined
Avoid Complexity
SOME GUIDELINES
40. 40
ATTACHMENTS
Any forms, logs or other documents that
are
essential to the execution of the SOP and
mentioned in the SOP shall be attached
to the SOP
41. 41
REVISION HISTORY
This will include a detailed list of what changed
In the revision
It is extremely important to know
What changed and when
(Inspections, Accidents, Attorneys)
43. 43
REVISION OF SOP
• When new equipment or process creates
new work situation
• Modifying work behavior improves
performances
• Incident investigation shows inadequate
safety and environmental requirements
44. 44
Routine Revision:
•At the end of review period by HOD concerned to the particular SOP will
review and revised if required.
•If there is no change then HOD just give the review report that this SOP
does not require revision and continue with the same till next review
period.
During the review period revision
•By the process owner with the approval of HOD, fill up the change control
form and SOP will be revised with new revision and effective date.
•As per the same Previous version will be superseded or obsolete
Final Approval of any change in the SOP will be
given only by QA department
REVISION OF SOP
45. 45
IMPLEMENTING SOP
• The most important step for implementing the SOP in working
area, train or retrain the user.
• While training the user, trainer should the reason WHY, SOP
MUST PERFORM CORRECTLY. People are much more to
follow when they understand the 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 the product by providing safety and
accuracy which will ultimately increase the confidence of the
user.
46. 46
MANAGEMENT OF SOP
• There should be record for issue and distribution of
SOPs.
• It is the responsibility of the process owner
To ensure that SOPs are current.
Eliminates obsolete SOP
Ensure that SOP meet their quality requirement and are user
friendly
Manage SOP change control
Distributes SOPs
Ensure that new or changed SOPs are valid only after training has
occurred.
Measures system performance and periodically reports result to
the management.
Continuously improves the system
47. 47
COPIES OF SOPS
• Master copy
Original signed copy
• Controlled copy
Used at actual working place
• Uncontrolled copy
For information purpose only
• Obsolete copy
For obsolete activity
• Supersede copy
Previous copy which is replaced with new one
• Approved copy
For the Dossier and regulatory submission
50. 50
VALIDATE YOUR SOP
Validation means:
•To establish the soundness of; corroborate.
•To confirm that steps in the SOP are accurate.
51. 51
Initial
validation
• Give the “draft” SOP to 1-2
people to read and perform
/evaluate /comment
Re-edit
draft
• Make corrections
Re-
validate
• Final validation
Assign
SOP #
Final
Approval
52. • How much someone knows about an entire process
or job affects the way he or she does that job.
Incorporate safety, health and environment into the
traditional how-to-operate or how-to-do steps. This
teaches the person comprehensively or holistically so
he or she has a complete picture of the
responsibilities for doing a job properly. This
simplifies follow-up training.
52
IMPORTANT TIPS TO KEEP IN
MIND WHEN WRITING SOP
53. 53
• Write an SOP as long as is necessary for a
specific job. All jobs differ in the number of
steps required to complete them properly.
Write an SOP to satisfy the definition of an
SOP
IMPORTANT TIPS TO KEEP IN
MIND WHEN WRITING SOP
54. 54
• People tend to ignore long SOPs because they
cannot remember more than 6 to 8 steps. If your
SOP goes beyond 8 steps, consider these
solutions:
Break a long SOP into several logical sub-job SOPs,
Write an accompanying shortened SOP that lists only the
steps but not detailed explanations of those steps, and
Make the long-form SOP a training document or manual
to supplement the shorter sub-job SOPs mentioned earlier.
IMPORTANT TIPS TO KEEP IN
MIND WHEN WRITING SOP
55. 55
• Prepare the longer comprehensive training
SOP first to get a picture of what training is
needed. Then decide how to break it into
shorter sub-job SOPs. Writing sub-job SOPs
first, and then trying to put them together,
may leave out linkage steps that make sub-
jobs interdependent.
IMPORTANT TIPS TO KEEP IN
MIND WHEN WRITING SOP
56. 56
• Write SOPs for people who perform work under
different interpersonal circumstances.
I. Write some SOPs for people who work alone.
II. Write some SOPs for two or more people who work
together as a team.
III. Write some SOPs for people who will supervise other
people doing a job.
IV. Write some SOPs for people who not familiar with rules
generally understood by your employees, for example,
SOPs for contractors, vendors or suppliers.
IMPORTANT TIPS TO KEEP IN
MIND WHEN WRITING SOP
57. 57
• Consider the work culture within which
people work. If you write for people in a
culture in which shortcuts are accepted
practice, explain the reasons behind certain
steps so that SOP users will understand the
importance of following all the steps in the
proper order.
IMPORTANT TIPS TO KEEP IN
MIND WHEN WRITING SOP
58. 58
• Consider the age, education, knowledge,
skill, experience and training, and work
culture of the individuals who will be
performing the SOP steps.
IMPORTANT TIPS TO KEEP IN
MIND WHEN WRITING SOP
59. 59
• Keep in mind that many people do not read all the
steps before starting with step one. Many people
read one step, perform it, read the next step,
perform it, and so on. To try to get around this
habit, forecast future effects and steps at certain
points in the SOP to tell reader things they should
know in advance, such as upcoming steps that
require caution, precision, timing, assistance, and
personal protective equipment.
IMPORTANT TIPS TO KEEP IN
MIND WHEN WRITING SOP
60. 60
• Once you have completed writing an SOP, have
several workers test it and give you feedback. If
you did not consult safety, health and
environmental experts prior to writing the SOP,
have them observe the SOP being tested so they
can add comments.
IMPORTANT TIPS TO KEEP IN
MIND WHEN WRITING SOP
61. 61
• Review the effectiveness of SOPs after a
few weeks and make necessary changes if
in-the-field practice suggests that
descriptions should be improved.
Review SOPs when processes and equipment
are changed.
When new equipment is installed, take the
opportunity to write a new SOP, incorporating the
good from the old, and adding what is necessary
to satisfy the new equipment
IMPORTANT TIPS TO KEEP IN
MIND WHEN WRITING SOP
62. 62
SOMETHING SPECIAL
ABOUT SOP
The best SOP is one that accurately transfers the
relevant information and facilitates compliance with
reading and using the SOP
&
The best written SOP will fail if they are
not followed
63. 63
SOMETHING SPECIAL
ABOUT SOP (cont..)
• Failure to follow company’s own procedure is one of
the common observation found during FDA
inspection.
• Employee will give many reasons why they find
reading and following SOP to be difficult and time
consuming. Most of these reason concern content,
clarity and training
67. THANKS GIVING
67
If you find this presentation of some
value and need more details on any
of the aspects, please do not hesitate
to get in touch with me at:
dr.akpurohit@hotmail.com
Visit: www.drarun-pharma-advisor.com
