STANDARD OPERATING PROCEDURE

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.

Responsibilities

Parts of SOP SOP Header SOP Body SOP Footer

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:

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

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.

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

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

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

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

Formatting of the SOP Paper size shall be A-4 with width of 8.27 inch and height of 11.69 inch.

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:

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)

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

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 1.1.1.1.1, 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.

Copies of the SOP

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