SOP Format, SOP Template of WHO

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Know about the Standard format of Standard Operating Procedure for pharmaceuticals suggested by WHO (World Health Organization).

All SOP structure is Why, When, Where, Who, What, How and What next.

Name of Facility____________________    Page of________________

SOP No.______________Title_________________________________

Department__________Date___________________________________

Revision Number_____________ Effective Date___________________

  1. Objective:

          Why:

          Why is this Standard Procedure written?

Why is it being performed?

  1. Scope:

          When:

It is indicate that when this procedure needs to be performed.

          Where:

It is tell about where this procedure applies.

  1.  Responsibility:

          Who:

It is indicate that who performs the procedure and who is responsible to see it performed correctly.

  1. Material and equipment :

         What:

Indicate what is needed to activity, task and test.

  1. Procedure:

          How:

How to perform the procedure.

It should be written clear concise with step by step instruction.

Fundamental principles can be included if necessary. It should include are following:

  • Preliminary steps:

It should be done before beginning the actual procedure.

  • Safety consideration:

Safety consideration indicates the work time precaution with physical, chemical and biological hazards.

  • Chronological instruction:

It is help to reduce SOP length. It is useful to number the steps so the repeat step can be referred.

  • Calculation:
  • If any calculation required then give explanation and sample how to do it.

        Reporting :

        What Next:

Where result should be recorded, explain what to do if any problem occur during activity, any deviation               must be approved and recorded and person identification whom the final result should be reported.

 

  1. Abbreviations:

It is a list of explained words used in short form in document.

Example: SOP                  Standard Operating Procedure

  1. Reference documents:

List of others SOP or document which directly affect or relevant this procedure.

        Written by_______________Edited by_____________

Authorization Signature _________________________

 

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