1. STANDARD OPERATING PROCEDURE

2. Definition
Standard Operating Procedure (SOP) is a document where step by step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.

3. Responsibilities

4. Parts of SOP
SOP Header
SOP Body
SOP Footer

5. STANDARD OPERATING PROCEDURE
Content of the Header
Company Logo
PHARMACEUTICALS COMPANY NAME
STANDARD OPERATING PROCEDURE
SOP No. :
Title:
Revision No. :
Supersedes :
Page No. :
Prepared by
Checked by
Approved by
Deptt. Head
Head QA
Sign & Date
Name
Designation
Effective Date: Next Review Date:

6. Content of the SOP Body Objective (why SOP prepared)
Scope (to whom applicable)
Responsibility
Accountability
Abbreviations and Definitions
Procedure
Forms and Records
Distribution
History

7. Content of the Footer
Only Form no. shall be written in footer at left side corner of the page and outside of page border
Form number shall be typed in footer as ‘Form No.: SOP/QA-001/F01-00’, in regular fonts in font size 10.

8. Language of the SOP Clear, instructive, sequential, unambiguous
SOP should be written in short, clear sentences and preferably in a passive voice
Where required, for operational purpose, any SOP is to be translated in vernacular language

9. Initiation of a new SOP Draft copy of the SOP
Review by Initiator Department Head
Review by QA personnel
Corrections to be done
by initiator
department
Review by QA Head/Designee No
Yes
Final approval by QA Head/Designee
QA personnel takes out the print of
final SOP

10. Numbering System of SOP
SOP/XX-YYY, where
SOP – Standard Operating Procedure
XX – Department Code
YYY – Serial number of the SOP, starting from 001.

11. Formatting of the SOP
SOP shall be neatly typed using Microsoft Word application software.
Orientation of page shall be portrait. Landscape orientation shall also be used in annexures

12. Formatting of the SOP
Paper size shall be A-4 with width of 8.27 inch and height of inch.

13. Formatting of the SOP
Margins setting on word file shall be as follows:
Top margin shall be 0.8 inch (0.8”)
Bottom margin shall be 0.6 inch (0.6”)
Left margins shall be 0.6 inch (0.6”)
Right margin shall be 0.6 inch (0.6”) as described below:

14. Formatting of the SOP
Page Layout from edge shall be header 1” and Footer 0.4”.
Page border’s line width shall be 1 point (1pt)

15. Formatting of the SOP
Line spacing between the lines shall be as follows:
Before: 0 pt
After: 0 pt
Line Spacing: Single

16. Formatting of the SOP
All the points in the SOP shall be numbered sequentially.
A outline system of numbering shall be followed as follows: First level shall be 1.0, 2.0, and 3.0 …….so on, Second level shall be 1.1, 1.2, 1.3……..so on, this shall continue up to fifth level and fifth level shall be , and after this level sub-numbering can be marked as ‘a’, ‘b’ and so on or ‘i’, ‘ii’ and so on.
In case where numbering of sub-paragraphs are not necessary and listing is essential, bullets or other suitable identification marks may be used to illustrate the same.

17. Copies of the SOP

18. THANK YOU!