SOP advice

SOPs, Standard Operating Procedures, are hallmarks of all GMP operations. Regardless of the size of the company, the number of such instructions is often in the hundreds, and the trend is rising. But: Deficiencies in official inspections do not only relate to missing or incomplete SOPs. The unmanageable flood of documents is also a deficiency that certainly appears in an authority report. Living GMP means doing what is described in each individual SOP. And therefore also requires a clear overview and controllability of the entire system.

Process versus paper

SOPs serve to ensure that standard processes run reliably. They help to avoid errors, prevent loss of knowledge and make it easier for new employees to get started. SOPs must be clear, understandable, short, concise and yet precise. The process, not the paper, is important and takes center stage. That's why Medcycle experts first spend time on process analysis before creating SOPs, conduct interviews with those involved, and record and structure the process. Only then is it fixed on paper, packed into comprehensible sentences and surrounded by the necessary form. This is how we arrive at SOPs that actually depict the ideal process and support it in day-to-day operations. 

Templates – basis for specifically designed SOPs

On the subject of SOPs, there are a large number of sample templates, cheaply available on the Internet. Copy, paste, modify slightly, sign, done!? 

Better not! The authority notes a deficiency, if it recognizes a copy and paste variant or an unspecific paper. It is important to reflect what actually happens in the company. Proven templates serve here as a basis, as a structuring checklist, and bring time and cost efficiency. The real expert work, however, lies in the process analysis and the specific design of the final SOP. 

Too much of a good thing - SOP system optimization

Setting up SOP systems and writing SOPs is a central service. However, the optimization of an SOP system is more and more often the focus of projects, because these grow over time, are successively supplemented and sometimes get out of hand. The overview is lost. What is missing, what can be dispensed with? Where can content be linked thematically, avoid duplication, make the system more flexible through correct referencing? These are increasingly the challenging questions today. If the system is properly optimized, living with GMP and acting along the SOPs will be noticeably easier and more efficient.

Get out of the house – external SOP maintenance

Creating SOPs is a demanding task, maintaining them, keeping them up to date, distributing them, collecting them, archiving them is another. At least one person who takes care of it comprehensively is required - regardless of the size of the company. This can exceed the resources of individual departments or small companies, and outsourcing such tasks can be an economical, sensible solution. Medcycle takes over the professional maintenance, administration and distribution of SOPs, makes them available centrally via electronic platforms and ensures that they are up-to-date with regard to new regulatory changes. As an external GMP office.