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  • bb254 replied to the topic How to write SOP ? Which SOPs are for cGMP ? in the forum Device Documentation 7 years, 1 month ago

    SOPs layout the details for the standards a company implements in the procedures and processes. SOPs that I have worked with include a purpose, procedure, documents/ fixtures affected, forms and attachment sections. All SOPs should be written in a concise format that does not lead to questions. When an auditor reviews an SOP they will look up all the documents associated with that SOP so make sure to reference the accurate documents. An auditor might even take the SOP to the production floor and see if the operators are following what is stated in the SOP. Therefore, when writing the procedure section of an SOP go to the production floor to see how the operators go about a completing a process. Include images in the SOP to make things clear and understandable to those who never heard about a fixture or process.