SOP Generation in Pharmacovigilance

Estimated reading time: 2 minutes


In pharmacovigilance, as in any other field, having well-defined Standard Operating Procedures (SOPs) is key to ensuring compliance with regulations and consistency in the performance of tasks. The generation of SOPs is therefore a critical part of our work.

Below, we will share my top tips on how to generate SOPs that are both compliant and fit for purpose. Follow these tips and you'll be sure to create SOPs that everyone will love!

  1. Know your audience - who will be reading these SOPs? Will they be used by PV staff only, or will they need to be accessible to other teams such as Regulatory Affairs or Clinical Trials? Keep this in mind when deciding on the level of detail to include.
  2. Keep it simple - SOPs should be written in clear and concise language that can be understood by all. Avoid jargon and abbreviations where possible.
  3. Be specific - each SOP should cover one specific task or activity. If you find yourself writing an SOP that is too long or covers multiple topics, it may be worth breaking it down into smaller, more manageable pieces.
  4. Get input from others - don't try to go it alone! Make sure to consult with colleagues, subject matter experts, and/or management when developing new SOPs.
  5. Follow the format - there is no magic formula for the perfect SOP, but most follow a similar structure: including sections on purpose, scope, responsibilities, procedures, etc. Make sure to check with your organization's Pharmacovigilance department or Quality Assurance team to see if there are any specific requirements for the format of your SOPs.
  6. Take your time - rushing through the development of new SOPs is a recipe for disaster. Make sure you allow sufficient time for review and revision before finalizing any new procedures.
  7. Use templates - there's no need to start from scratch every time you need to create an SOP. There are many great template options available online (just do a quick search on Google) or ask your organization's PV department if they have any templates you can use.
  8. Proofread - this may seem like an obvious one, but it's important to make sure your SOP is free of spelling and grammar errors before sending it out for review. A poorly written SOP can reflect poorly on you and your department so take the time to proofread carefully!
  9. Get feedback - once you've completed a draft of your new SOP, send it out for review and collect feedback from those who will be using it. This is a great way to identify any potential issues or areas needing clarification before finalizing the procedure.
  10. Make revisions as needed - based on the feedback you receive, make any necessary revisions to your draft SOP before finalizing it. Be sure to keep track of all changes made so that you can easily reference them later if needed.
  11. Save & distribute - once your new SOP is finalized, save it in a central location (such as a shared network drive) where it can be easily accessed by those who need it.
  12. Train employees - once your new SOPS are published, make sure all relevant employees receive training on how to comply with them.
  13. Review & update regularly - finally, don't forget to review and update your existing SOPs on a regular basis (at least annually) to ensure they remain accurate and up-to-date.

There you have it, some top tips for generating compliant and fit-for-purpose Standard Operating Procedures in pharmacovigilance! By following these tips, you'll be sure to create SOPs that everyone will love! And remember…review & update regularly! Or contact Alphanumeric Systems for help getting started.

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