Standard Operating Procedures

Standard Operating Procedures (SOPs) are the backbone of your company as they cover all of your procedures and processes. If they are not correct, or representative of your company, it will negatively impact your operations causing deviations, deficiencies and risks. You must not copy SOPs from another company, no matter how similar their business model is to yours. We know that creating SOPs from scratch can feel time-consuming but it will take up even more time, and money, if you get it wrong and have to re-do them.

You should have a basic SOP template to ensure that all SOPs have the same layout and to make sure you haven’t missed any crucial areas, as well as an Index should all SOPs which should be numbered (helps with referencing).

They will need to be compliant with the EU GDP Guidelines (2013/C 343/01), so you should have a copy to work from when creating all SOPs. We also recommend purchasing the ‘Green Guide’ which goes into further detail on what is required and how to implement the guidelines.

The MHRA will be looking at your SOPs during an inspection to ensure they are compliant and meet their expectations. If the inspector finds that they are not up to scratch the will be a non-conformity and if it leads to critical deviations due to risk to human health there could be serious consequences for the company (e.g. suspension of licence and/or renewal of your RP).

We can create a new set of SOPs for your company once we have taken a look at your business model. Alternatively, we can review your existing set and advise you on what needs to be changed. Contact us if you feel this service would be suited to your needs.