a detailed project on standard oprating procedure (SOP) in the elective subject of GMP A standard operating procedure (SOP) is a set of step-by-step instructions compiled by an organization to help workers carry out complex routine operations. SOPs aim to achieve efficiency, quality output and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations.

1. GOOD MANUFACTURING PRACTICES
PROJECT REPORT
(ON STANDARD OPERATING PROCEDURE)
A Project is submitted
In partial fulfillment
Of the requirement for the degree of
BACHELOR OF PHARMACY
By
HARISH SHARMA
ROLL NO.:- 1564150022
Under the supervision of
ABHISHEK GUPTA
(Associate Professor)
AITM Varanasi
To the
Faculty of Pharmacy
A.P.J. Abdul Kalam Technical University
Lucknow
APRIL, 2019

2. BONAFIED CERTIFICATE
This is to certify that the project entitled work presented in this report Standard
Operating Procedure (SOP) is a record bonafied work carried out by
HARISH SHARMA of B-Pharma 4th
Year with roll no-: 1564150022 in
Good Manufacturing Practices (GMP) prescribed by Department Of
Pharmacy.
Date: ________________________
Internal Examiner :___________________________
External Examiner:____________________________

3. ACKNOWLEDGEMENT
It gives me immense pleasure in presenting this project report on “Standard
Operating Procedure (SOP).”. I have taken great efforts in this report.
However, it would not have been possible without the kind support and help of
many individuals .I would like to extend my sincere thanks to all of them.
I am highly indebted to my guide Mr. ABSHIEK GUPTA (Associate
Professor) for his guidance and constant supervision as well as for providing
necessary information regarding the report and also for his support in
completing the report.
I would also like to express my gratitude towards my parents and friends and
seniors my for their kind co-operation and encouragement which helped me in
completion of this report.
My thanks and appreciation also goes to those people who have willingly
helped me out with their abilities. The project is dedicated to all those people
who helped me while doing this project.
Date:
HARISH SHARMA
B. Pharma (4th
Year)
Roll No.- 1564150022

4. CONTENT
1.0 Introduction ...........................................................................................................1
1.1 Overview..................................................................................................................1
1.2 Purpose.....................................................................................................................1
1.3 Benefits .....................................................................................................................2
1.4 create SOP to grow..................................................................................................2
1.5 Writing Styles ..........................................................................................................3
1.6 How to write SOP....................................................................................................3
1.6.1 State the "Why"....................................................................................................3
1.6.2 Frame the Process.................................................................................................4
1.6.3 Create Detailed, Concrete Steps...........................................................................5
1.6.4 Test the SOPs...........................................................................................................5
1.6.5 Most Importantly: Store and Review Periodically................................................6
1.6.6 Making SOPs "Living Documents".......................................................................6
2. 0 SOP Process................................................................................................................7
2.1 SOP Preparation.........................................................................................................7
2.2 SOP Review and Approval ........................................................................................7
2.3 Frequency of Revisions and Reviews.........................................................................8
2.4 Checklists......................................................................................................................8
2.5 Document Control........................................................................................................9
2.6 SOP Document Tracking and Archival ....................................................................9
3.0 SOP general formate....................................................................................................10

5. 3.1 Title Page .................................................................................................................10
3.2 Table of Contents.....................................................................................................10
3.3 Text ............................................................................................................................10
4.0 Types of SOPs ...........................................................................................................11
4.1 Technical SOP Text Information Guidelines............................................................11
4.1 Quality Control and Quality Assurance Section.......................................................13
4.2 Reference Section...........................................................................................................14
4.3 Other good practices.......................................................................................................15
4.4 Responsibilities of the Quality Unit........................................................................16
4.5 Responsibility for Production Activities..................................................................17
5.0 Example of SOPS.............................................................................................................18
5.1 SOP For Disintegration Tester.................................................................................18-22
5.2 SOP for Operation of High Speed Centrifuges.........................................................23-25
6.0 Reference........................................................................................................................26