The document provides a comprehensive overview of quality assurance and standard operating procedures (SOPs) in the pharmaceutical industry, emphasizing their importance for maintaining product quality and regulatory compliance. It outlines the purpose, preparation, formatting, and maintenance of SOPs, alongside their benefits, such as consistency in operations and compliance with manufacturing standards. Key points include the necessity for training on SOPs, the significance of document control, and the ongoing review process to ensure relevancy and effectiveness.

1. QUALITY SQUARE INDUSTRY
1

2. Quality
Sum/total of all the characteristics of a product/service that
has a bearing upon the utilization of the product/service to the
entire satisfaction of the end user.
Quality Assurance, Quality Square Industry 2

3. Cont…
Consistency
• Accuracy
• Precision
Right result
• First time
• Every time
Quality Assurance, Quality Square Industry

4. SOP
• Standard Operating Procedure is a step by step procedure or
Directions as established by a Quality Square Industry involved
in facility producing a product, testing or research.
• A Standard Procedure does not need explanation or publication
because it is standard.
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5. The procedure for describing the writing, revising and
approving of SOPs and the control of distribution of SOPs is
one of the important Quality Assurance procedure.
“Quality is everyone's responsibility”
- W. Edwards Deming
Quality Assurance, Quality Square Industry 5

6. Purpose Of SOP
[SCHEDULE M]
[See Rules 71, 74, 76 and 78]
• GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF
PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL
PRODUCTS.
• Note: - To achieve the objectives listed below, each licensee shall evolve
appropriate methodology, systems and procedures which shall be
documented and maintained for inspection and reference; and the
manufacturing premises shall be used exclusively for production of drugs
and no other manufacturing activity shall be undertaken therein.
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7. Cont…
CFR Part 211 : Current Good Manufacturing Practice For
Finished Pharmaceuticals
Subpart F 211.100 Written Procedures and Deviations
“(a) There shall be written procedure for production and process control
designed to assure that drug product have the identity, strength, quality
and purity, they purport or are represented to possess.”
(b) Written production and process control procedures shall be followed in
the execution of the various production and process control functions and
shall be documented at the time of performance. Any deviation from the
written procedures shall be recorded and justified. “
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.100
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8. Cont…
CFR Part 820 : Quality System Regulation
Sec. 820.40 Document controls.
Sec. 820.70 Production and process controls.
Sec. 820.80 Receiving, in-process, and finished device
acceptance.
• “Firms must “establish and maintain” procedures. To do so, companies
should define, document (either on paper or electronically), and
implement standard operating procedures (SOPs). Additionally,
companies must then follow up, review, and revise these documents as
needed.“
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=820
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9. Cont…
• ISO 9001- 2008, Clause 4.2 : Documentation requirements
“Documented procedure”, has to be established, documented, implemented and maintained.”
• IS/ISO 14001 : 2004 , Clause 4.5.4 : Control of records
“ The organization shall establish, implement and maintain a procedure(s) for the
identification, storage , protection, retrieval, retention and disposal of records.”
• IS 18001 : 2007 , Clause 4.4.5 : Control of Documents
“ The organization shall establish, implement and maintain a procedure(s) for the Controlling
all documents required by the OH&S management systems and by this standard.”
• ICH Good Manufacturing Practice Guide for API Q7, Section 6 Documentation
and Records
“ All documents related to the manufacture of intermediates or APIs should be prepared,
reviewed, approved, and distributed according to written procedures.”
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10. Benefits of SOP
1. To perform a job properly.
2. To ensure that production operations are performed consistently.
3. To ensure that processes continue uninterrupted and are completed on a
prescribed schedule.
4. To ensure that no failures occur in manufacturing and other processes for
which the SOP was written.
5. To ensure that approved procedures are followed in compliance with
company and government regulations.
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11. Cont…
6. To serve as a training document for teaching users about the process.
7. To serve as a checklist for co-workers who observe job performance to
reinforce proper performance.
8. To serve as a checklist for auditors.
9. To serve as an historical record for the Change over.
10.To serve as an explanation in review of accident investigations.
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12. SOP Maintenance
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13. A. SOP Preparation
• Should be written by individuals knowledgeable with the activity
and subject-matter experts.
• By an individual who performs the tasks routinely or someone who
is directly responsible for the performance of the task like…
 Those who will perform the job
 Those who will perform maintenance on equipment involved in an
SOP
 Engineers or others who design equipment and processes
 Technical initiator
 Safety personnel
 Environmental personnel
 Equipment manufacturers
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14. SOP Format and Content
There is no FDA approved format for a SOP.
SOP AND DECISION FOR FORMAT TYPE
Does SOP Does SOP
involve consist of Best format for writing
Sr. No. Examples
many more than 10 SOP
decisions? steps?
1 No No Simple sequential steps SOP for balance calibration
Sequential steps along
2 No Yes Entry / Exit procedure
with Pictorial diagrams
Sequential Steps with SOP for deviation
3 Yes Yes
Flow chart management
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15. Typical Structure of SOP
The content of a Standard-Operation-Procedure should
include the following minimum
• Title page • Responsibilities & accountabilities
• Hester’s Logo • Procedure
• Header with title of SOP • Footer
• Department Name Approving Signatures
• Effective date  Prepared by
• Revision date  Checked by
• Review date  Approved by
• Page No • Stamp
• Regulatory basis  Controlled Copy/Master Copy
• Reference documents  QA Stamp
• Purpose
• Scope
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16. Title Page
1. STANDARD OPERATING PROCEDURE
2. Logo of the Quality Square Industry.
3. Document Number
4. SOP Number
5. Title of the SOP
6. History of SOP
7. Revision Date
8. Writer
9. Replace page if any
10. Checked by
11. Approved by
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17. Text Format of SOP
• Logo of Company must be as below. Any other Logo will not be approved.
• Header : from Top Distance = 0.13
• Header Table for Title: Total Height : 0.2
• Then Do Auto fit as below
• Footer : From Bottom Distance = 0.13
• Paper Size = A4
• Page Margin : RIGHT , LEFT, TOP, BOTTOM = 1”
Page Indent and Spacing LEFT, RIGHT, BEFORE, AFETR = 0”
• Line Space: 1.0”
Table should be in the following format
• TABLE: Row Height Space = 2'
Text Font
• Font Style = Tahoma, Font Size = 10
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18. Quality Square Industry
SOPs & Formats
180
163
160
144
140 SOP
Formats
120
100 91
Quantity
80
60
38
40
30
18
20 12 13
9 9 10 10
2 4
0
Q.A. STORE PRODUCTION Q.C. LOGISTIC I.T. H.R.
Department
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19. SOPs
• Master copy
Original Signed copy
• 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 with new one
• Approved Copy
For the Dossier and regulatory submission
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20. SOP and Guideline
• SOPs provide a specific view of all the main steps whereas
guidelines are significantly more detailed.
• Some SOPs have a two-tiered system that includes both SOPs
and guidelines.
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21. TITLE : Making Coffee Date of original Version :
Revision Date :
APPROVED BY : EFFECTIVE DATE :
Making COFFEE
1. PURPOSE
To make 1 cup of Coffee for the Employees wanting coffee according to the Hester site
standards.
2. RESPONSIBILITIES
Personnel who want to make coffee.
3. PROCEDURE
3.1 Take 500 ml S.S. Bowl, ensure the Bowl is clean and empty.
3.2 Fill the Bowl with 100 ml of potable water.
3.3 Add 2 teaspoon of Nescafe in water of Bowl.
3.4 Place the Bowl on the Stove. And lighten the Stove.
3.5 Boil for 10 minutes. (Color of the mixture will be dark brown)
3.6 Filter the mixture into the coffee cup directly.
3.7 It is ready to serve.
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22. Guideline : Making Coffee
Date : 0 1/26/07
1. Ensure Stove is working
a. Check the knob of the regulator of stove, it should be in “on” position.
b. Lighter or match box should be in place.
2. Wash out S.S. Bowl if needed
a. Dishwashing soap is located in the cupboard under the sink.
b. Use hot water and a small mount of dishwashing soap.
c. Brush with a small brush located on the hook under the sink.
d. Rinse thoroughly with hot water.
e. Instead of S.S. Bowl one can use Aluminum Bowl too.
3. Taken out Nescafe
a. Use spoon to take out the Nescafe.
b. After taking out Nescafe close the container tightly.
4. Making of coffee
a. Take sufficient amount of water in Bowl.
b. Add sufficient amount of Nescafe to the water of Bowl.
c. Place the Bowl on the stove and lighten it.
d. Boil the mixture for enough till mixture get dark brown in color.
5. Filter the mixture using filter into the another vessel.
a. Filters are located in the drawer directly under the stove.
b. After filtration, keep the filter aside for washing in sink.
6. Serve Coffee in HOT .
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23. Flow diagram for SOP preparation and implementation
Revised Document
START
No
Solicit feedback
New Document or Cerate A Yes
from affected General Agreement
Change in Existing Draft Copy of
Individual or
Document Needed Document
Group Create Draft
Copy of
Change order
On effective date Train Affected
Process Yes Submit for
update master and Individuals and
Release of Document Approved formal Review
controlled Create Training and Approval
Document
procedure copies records
No
END Revised Document
As and CO
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24. Points of Consideration
1. Incorporate points by which one can get idea why to do that job and
complete picture of the responsibilities for doing a job properly.
2. If your SOP goes beyond 10 steps, then break the long SOP into several
logical sub-job SOPs.
3. Write SOPs for people who perform under different interpersonal
circumstances.
o Write some SOPs for people who work alone.
o Write some SOPs for two or more people who work together as a team.
o Write some SOPs for people who will supervise other people doing a job.
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25. Cont…
4. Write some SOPs for people who not familiar with rules generally
understood by your employees. For example, you may write for
contractors, vendors or suppliers.
5. Consider the work culture within which people work.
6. Consider the age, education, knowledge, skill, experience and
training, and work culture of the individuals who will be performing the
SOP steps.
7. Once you have completed writing an SOP, have several workers test it
and give you feedback.
8. Review the effectiveness of SOPs after a few weeks and when Processes
and equipment changed and make changes as per it.
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26. B . SOP Review & Approval
• Review period for the Hester’s Document is 2 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 of approach
 Degree of completeness
 Testability of requirements
 Use of appropriate requirement, design, or coding techniques
 Appropriate level of details
Reference : http://www.wildfire.gov/pmu/pmo-rchive/products/documents/Review_Guidelines.pdf
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29. C SOP Revisions
Routine revision
• At the end of the review period by HOD concerned to the particular SOP
will review and revise if required.
• If there is no change then HOD just give the review report that this SOP
doesn’t require review and continue the same for the next review period.
During the review period revision
• By the process owner with the approval of the HOD, fill up the DCC
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 the any type of the change in the SOP is given only by the
QA department.
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30. D Implementing SOP
• The most important step for implementing the SOP in working
area, train or retrain the user.
• 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.
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31. E Management of SOP
• There should be the record for issue and distribution of the SOPs.
• It is the responsibility of the process owner to
 Ensures that SOPs are current.
 Eliminates obsolete SOPs.
 Ensures that SOPs meet their quality requirements and are user
friendly.
 Manages SOP change controls.
 Distributes SOPs.
 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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32. 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 SOPs will fail if they are not followed.
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33. • Failure to follow a company’s own procedures is one of the
common observation found during FDA inspection.
• Employees will give many reasons why they find reading and
following SOPs to be difficult and time consuming. Most of
these reasons concern content, clarity and training.
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34. Cont...
Too many poor SOPs could lead to a collapse of the whole System.
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35. Quality Assurance, Quality Square Industry 35

36. “Quality is not an act, its a Habit“
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