Sample SOP, Example SOP, SOP Format, SOP Template : Pharmaceutical Guidelines

Sample SOP, Example SOP, SOP Format, SOP Template

Know the Standard Format of the Standard Operating Procedure suggested by World Health Organization (WHO) for Pharmaceuticals.

Name of facility ___________________________________________________page_____of_____
SOP Number ___________ Title _____________________________________________________
Department ____________ Date __________________ Revision number ____________________
Effective date _______________

1.0  Objective:
       Why is this procedure written.
       Why is it being performed.
2.0  Scope:
       Indicate when this procedure needs to be performed.
       Indicate where this procedure applies.
3.0  Responsibility:
       Who performs the procedure, who is responsible to see it is performed correctly.
4.0  Materials and equipment:
       WHAT: What is needed to perform the test. The list should be complete and specific.
5.0  Procedure:
Clear concise, step by step instructions on how to perform the procedure.
This should be written as instructions for the operator to follow, without a lot of theoretical background. A section on fundamental principles can be included if necessary.
It should include:
a) Preliminary steps that must be done before beginning the actual procedure.
b) Safety considerations: Precautions for work with physical, chemical, or biological hazards (contaminate facility clothing, masks, hoods, goggles, gloves, cleanup of spills etc.).
c) The chronological instructions. It is useful to number the steps so that repeat steps can be referred to rather than making the SOP very long.
d) Calculations: Explanations and sample of how to do any required calculations.
6.0  Reporting:
       WHAT NEXT:
a) Indicate where the results should be recorded.
b) Explain what to do if there are problems during the test.
c) Indicate that deviations to the procedure must be approved and recorded.
d) Identify the person to whom the final results should be reported.
7.0  Abbreviations:
       List the explained words used in short forms in the document.
8.0  Reference documents:
List other SOPs which directly affect or are relevant to this procedure. For example, the SOP for making a buffer used in the procedure, or the SOP for the operation of a piece of equipment used in the procedure.

Written by ______________Edited by ______________Authorization Signature ______________

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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