Standard Operating Procedure – How to Create an SOPs Effective

Standard Operating Procedure – How to Create an Effective SOPs


Purpose as first point; an overview of the intention of preparation of Standard Operating Procedure shall be briefly mentioned under this heading.



Scope as second point; describes the site(s) / location(s) / plant(s) and/ or departments to which the Standard Operating Procedure is applicable.

Reference(s) & Attachment(s)


References as Third point; includes details of any references used in order to design the system. The references can be an official publication, any published literature, guidelines, instruction manuals etc.

Cross reference documents:

This Section contain cross reference SOPs or inter-linked departmental SOPs . Some SOPs are intimately linked to others. When information contained in more than one document is necessary to complete a task, it is useful to include a cross-reference section in each document.

Attachments/ Formats/ Annexure

Attachments as third sub-point; it shall enlist all specimen formats, specimen labels, flow charts or any other attachment with the SOP.

Definition & Abbreviation

Definition: Write down in this column wherever require the definitions of critical/ technical term related or used in SOP.

Abbreviations as fourth sub point; describes the meaning or explanation of term(s) which is (are) not common or having any specific meaning and expansion of abbreviation(s) used in the Standard Operating Procedure.


Responsibility as fifth point; specifies designation of the personnel and name of department that shall be responsible for implementation and compliance of the Standard Operating Procedure.

Procedure: This section shall divide into sub-section.

  1. describe the Safety/Precaution or EHS measure shall be prepared by as per requirement of SOP and
  2. describes the detailed procedure to be followed in simple and clear sentences. It may include the details of all operations, operational conditions and precautions to be taken, if any, etc.

If any coloured photograph is required for SOP then it can be incorporated in SOP

Revision History:

  • History of revision as seventh point; history shall contain a chronological record of significant changes/ modifications in an SOP,

What is Content of SOP Footer?

Contents of Footer

Prepared By: Signature with date of a concern department person who prepared SOP. Prepared by signature and date shall appear on each page of the SOP.

Checked By: Signature with date of a concern department person who checked SOP. Checked by signature with date and date shall appear on each page of the SOP.

Reviewed By: Signature with date of a QA person who reviewed SOP. Reviewed by signature and date shall appear on each page of the SOP.

Approved By: Signature with date of QA Head and Plant Head who has approved the SOP signature and date shall appear on each page of the SOP.

SOP Template: Operating Standard Procedure

About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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