This document provides an overview of standard operating procedures (SOPs), including their aims, writing style, format, and contents. SOPs are step-by-step instructions that establish uniform processes to help workers carry out complex, repetitive tasks. The goals of SOPs include promoting quality, efficiency, uniformity, and transparency. The document outlines appropriate styles and formats for writing SOPs, such as using active voice and a logical step-by-step progression. It also describes typical sections of SOPs like scope, responsibilities, materials, and procedures. Master batch records and batch manufacturing records are also summarized.

1. PRESENTED BY :
Sachin pawar MPHARM F.Y [QA]
GUIDED BY:
R.S. SAKHARE SIR
SCHOOL OF PHARMACY SRTMUN NANDED.

2.  1. SOP
 2.SOP WRITING STYLE
 3. CARE TO BE TAKEN DURING THE WRITING
OF SOP
 4.INSIDE THE SOP
 5. FORMAT OF SOP {HOW SOP IS WRITTEN}
 6. MBR
 7.BMR

3. STANDERD OPERATING PROCEDURE
SOP is the set of the step by step instruction complied by an
organization to help worker to carry out the complex routine
operation
this step of instruction is followed by the
routinely or repetitively
AIMS OF THE SOP :
1. Create the culture where quality objective are transparent
and well understand
2. They form the backbone of the pharmaceutical
3. To achieve efficiency
4. To achieve quality output
5. To achieve uniformity of performance
6. To achieve uniformity of quality

4. Standard Operating Procedures (SOP) for
Shimadzu UV-VIS in RH385:
PPE required
1.Gloves, lab glasses, lab coat
Turning on UV-VIS
1.Flip switch on the bottom left end of UVVIS
2.Open UVProbe 2.21 program
3.On the bottom, click on connect
A .V-VIS will go through a checklist of
items.
B .Click OK after checklist is finished

5. Taking Spectra
1.To take a background, fill 2 cuvettes with the same
solution, place them in the reference slot (R) and
sample slot (S), and click on Baseline
1.The program will ask for range of wavelength.
Type in 700 to 200nm, then click ok
2.Replace the cuvette in the sample slot with your
actual sample. Be sure that the cuvette is 2/3 full.
3.Click Start
4.After the scan is done, select where to save the data
5.To view data points, click on the icon that looks like
a paper with writing on it. (to the right of the icon with
an M in a circle)

6. 6.To organize data, copy and paste data onto
your own excel sheet
7.To save a single scan, go to file>save as
Turning Off UV-VIS
Click Disconnect
Flip switch on UV-VIS off
Always turn the system off when you do not
plan to use it soon to conserve the lamp life

7. SOP WRITING STYLE
SOPs shall be written in a concise, step by step, easy to read and follow
format.
 Information should not be complicated. The active voice and present
verb tense should be used.
Should be simple and short.
Routine procedures that are short and require few decisions can be
written using simple steps format.
Long procedures consisting of more than 10 steps, with few decisions
should be written along with graphical format or hierarchical steps.

8. .
Continued….
Procedures that require many decisions should be written along
with flow chart
 Requirement for document identification and control,
accountability and traceability responsibility must be included
with every SOP; this can be achieved by providing consistent
format

9. WHILE WRITING SOP:
Write in the presence tense.
 Don’t write in the past
conditional or future tense unless you have good reason to do
so.
 Avoid ambiguity.
Be concise.
 Keep the words short and get to point.
Move from one step to another step in logical manner.
 Highlight exception. Use a symbol to flag that this is an
exception and how to handle it

10. CONTINUED ….
Highlight warning. Again warn users that caution must
be used in this scenario. Warning must stand out; use a
larger font or a warning icon.
Reduce the word count where possible without altering
the meaning of the text.

11. WHILE WRITING SOP
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 and tell them what to do.

12. INSIDE THE SOP
Company name and pagination. The company name and pagination
(e.g. page 4 of 7) must appear on every page.
Title
The title should be descriptive. The title should use directive
language to declare what is being done to what.
Identification
Procedures must be easily identified by giving unique number and
version number. This identification number of the SOP supports
accountability of the document throughout the facility and over time
as it changes.

13. CONTINUED….
Review and approval
All SOPs shall have space for signature of
initiator (the person who has written the SOP)
Reviewer (The persons who has reviewed the SOP) and
approver (Quality Assurance Head of the organization).
Purpose
The purpose or objective of the procedure should restate
and expand well written title. Expand or qualify the
directive language used in the title (e.g. to describe the
operation procedure of compression machine)

14. Scope
The scope should provide limits to the use of
procedure. The scope shall be written in such a way
that it answers following questions….
 Are there certain samples that are appropriate to test
by this method?
Do these operations apply only to certain equipment
or certain departments?
 Is there a limit to the capacity, volume, or throughout
of the procedure?
 State to what areas this procedure does apply and
does not apply?

15. Responsibility
Who is responsible for performing the work
described? Who is responsible for implementing the
procedure?
Procedure
Describe the procedure in a step by step,
chronological manner. Use active verbs and direct
statements

16. GENRAL FORMAT FOR SOP
1.SOP Number:
2.Title:
3.Department:
4.Date:
5.Revision number:
6.Effective date:

17. 1.Objective:
why ?
2.Scope
When ?
where?
3.Responsibility :
Who?
4.Material equipment :
What?

18. 5.Procedure :
How?
It includes :
a. Preliminary test
b. Safety consideration
c. Chronological instruction
d. Calculation

19. 6. Reporting :
What next
7. Abbreviation
8. Reference document
written by …..
edited by…..
authorize sign..

20. Master Batch Records
Master Batch Records, also known as Master Production
Records and Master Manufacturing Records, are version-
controlled templates for your manufacturing process. Dietary
supplement manufacturing facilities are required to create
these documents and keep them on file, but what exactly is
the FDA looking for in a Master Batch Record?

21. In addition to a list of instructions for manufacturing each unique product and
batch size, the FDA is looking for:
A complete list of individual equipment and processing lines
Identification of all equipment and processing lines
Verification of cleaning and calibration activities
 Lot numbers and other control information for components, packaging and
labels
Sampling, inspection and results of testing activities
Control of issuance and labels
Quality control approval
Signatures

22. Batch Manufacturing Record BMR:
Batch Manufacturing Record (BMR) here "BMR" stands For Batch
manufacturing Record. This is one type of document which is product
and batch specific document which gives entire picture of
manufacturing history of each batch of every product.

23. Batch Manufacturing Record includes following things which is
based on master formula record.
1.Name of product
2.Trade Name
3.Specification of raw material
4.Name of raw material
5.Specification of container , closure and packing material
6.Name of item
7.Weighment sheet
8.Dispensing Instructions
9.List of equipment and machinery
10.Dispensing instructions

24. 11.Packaging requirements
12.Packaging instructions
13.Precautions to be taken
14.Finished product specifications
15.Expiry date
16.Review due on.

27. REFRENCES :
McMurdo Station Medical Standard Operating Procedures as of
2006/06" (PDF). Retrieved 2014-08-02.
Guidance on the Documentation Requirements of ISO
9001:2008 Archived October 15, 2011, at the Wayback Machine.
Taylor, G.A. (2012) Readability of OHS documents - A
comparison of surface characteristics of OHS text between some
languages, Safety Science, 50(7), 1627-16