Standard Operating Procedures (SOPs) are written instructions that are followed routinely to ensure consistency and quality control in pharmaceutical manufacturing. SOPs describe technical and operational processes and are required by regulations. They provide training guidance for employees and help maintain compliance. The document discusses the importance of SOPs, how they are developed and reviewed, and their implementation in ensuring consistent and proper procedures are followed.

1. PREPARED BY
MARTIN SHAJI
PHARM D
STANDARD OPERATING
PROCEDURE –SOP
(A BRIEF DISCUSSION)

2. Standard Operating Procedures (SOPs) are an integral part of Good
Manufacturing Practices. Without SOPs its really tough to run such
big infrastructures of Pharma Manufacturing Units. SOPs are also
required as regulatory requirements & every worker must be
aware of the SOPs related to his/her job function.
Introduction

3. STANDARD OPERATING PROCEDURE [SOP]
•:• Set of written instructions that is followed routinely or repetitively.
+ Created culture where Quality objectives are Transparent, well understood, and
Undoubtedly these goals can be achieved by certain sets of Procedures called as
“Standard Operating Procedures”.
+ Back bone of Pharmaceutical Industries.
+ SOPs describe both technical and fundamental programmatic operational
elements of an organization that would be managed under a work plan or a
Quality Assurance (QA) Project Plan. Simple terms SOP is...>A written pnxess A
way for the clinical site to perform a task the same way each lime it is completed.

4. REASONS FOR HAVING SOP
To provide people with all the safety, health, environmental and operational
information.
To ensure that processes continue uninterrupted and,. completed on a
prescribed schedule and maintain quality control of processes' and products.
To ensure that no failures occur ¡n any processes. To ensure that approved
procedures are fol1ocd incompliance with company and government
regulations..‘
To serve as an historical record of the whole process which is done and have
a basis of that when the process is changed. Provide training and guidance
for new staff.

5. SOP - AIM FOR QUALITY
‘Standard Operating Procedure Is a set of step by step
written instructions intended to document how toper form
a routine activity.
• Back bone of pharmaceutical industry. 'Integral part of
Quality assurance(QA).
• Provides details of appropriate quality, cost and time
constraints.

6. 1. Standard Operating Procedure
2. - Introduction
3. - Objectives
4. - Benefits
5. - Types of SOP
6. - SOP Writing Style
7. - DO’s
8. - Don’ts
9. - SOP Content
10.- SOP Process
Summary

7. SOP PROCESSS
Preparation of SOP
Review and Approval
Frequency of revisions and reviews
Implementing SOP
Management of SOP

8. To maintain the quality control & quality assurance.
To serve as a training document for teaching users about the process
for which the SOP was written.
To facilitate consistent conformance to quality system requirements Et
to support data quality.
To provide guidelines for accurate & timely data collection.
Reduce miscommunication & failure to comply with industry
regulation.
To carry out operations correctively & always insane manner.

9. To provide people with alt safety, health, environmental & operational
information necessary to perform the job property.
Serves as a training document for users.
Minimizes variation & promotes quality.
Steps can be reviewed in accident variations.
Useful toot for training new members of staff.
SOP assist to ensure that GMP is followed & achieved at alt times.
SOP’s help to assure the quality Et consistency of the services, Et thus
minimize harm to the patient.

10. SOP writing style
Write one SOP per study-related activity.
Ex: Performance of Lumbar puncture, handling, transport & storage
of CSF sample, microscopic detection of trypanosomes etc...
Do not mixed too many activities in one SOR
Make sure you are familiar with the procedure to be described in the
SOR If you are not, ask somebody who performs the procedure
regularly to show it to you.
Describe in detailed how the procedure is being carried out

11. List of the steps in chronological order
as in the example below
Making a cup of tea:
1. collect a cup & saucer.
2. 2. place teabag into cup
3. 3. boil water in kettle
4. 4. add water to cup & teabag
5. 5. allow tea to infuse
6. 6.remove teabag
7. 7. add milk & sugar (if desired)

12. Sop process
Sop Preparation
Sop Review & Approval
Frequency of revisions &
Reviews Implementing SOP
Management of SOP

13. SOP review & approval
Review factors a criteria are:
Adherence to standard
- Consistency and traceability
- Readability, corn apprehensibility, and general
understandability
- Technical adequacy a feasibility of approach
- - Degree of completeness. Testability of requirements. Use of
appropriate requirement, design, or coding techniques.
Appropriate Level of details

14. SOP Revisions
Routine revision:
. At the end of the review period by HOD concerned to the
particular SOP Will review & revise if required.
. If there is no changes then HOD just gives there view report
that this SOP doesn’t require review& continue the same for
the next review project.

15. implementing SOP
The most important step for SOP in working area, train or
retain the user. White 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.

16. Management of SOP
There should be the record for issue &distribution of the SOP’s.
It is the responsibility of the process owner too Ensure that SOP’s
are current.
Distributes SOP’s.
Eliminate obsolete SOP’s.
Continuously improve the system.
Ensure that SOP’s meet their quality requirement& are user
friendly.

17. What kind of SOPs are needed?
Routine instrument maintenance
?Glassware washing
?QAU
?Computer
?SOP for SOPs
?Analytical method
?Specific procedure for initial research project?

18. Content of sop
Company name & pagination
Title
Identification
Review & Approval Purpose.
Scope
Responsibility
Procedure

19. • Analytical method
• Preparation of Reagent
• Quality Assurance
• For operating instruments, equipment and apparatus
• Safety & Precautions
• Methodic
• Receiving and registration of sample
• Fundamental SOP. To deal with complaints
Types of sop

20. Write in present tense. don’t use past tense, condition of future
tense unless you have good reason to do so.
Avoid ambiguity & be concise.
Reduce the word count where possible without changing the
meaning of the text.
Highlights exceptions. Use a symbol to flag that this is an exceptions
& how to handle it.
Highlight warnings & use a Longer or a warning icon.

21. Introduce acronyms without explaining what it means.
Don't use the word “may”, “ if possible” as it implies that the user
can do something under conditions.
Instead be positive & tell them what to do.

22. Position of sop in total
documentation