PMS procedure vs PMS plan

[QuaffReg]

Hi,

Can anyone help on the difference between what should be included in a PMS SOP and in a PMS Plan, please ? I know the PMS Plan is product specific but as we currently have only one range of product on the market, I'm feeling that both of the documents have very similar content. Can someone please guide me ?

Many thanks

 

[Philip B]

I keep our procedure very broad-brush and simple. I cover responsibilities plus a reference to the plan and report and not much else. I then put all of the detail into the plan. Not had any push-back so far.

 

[Cloud808]

IMO, the procedure should address the requirements of the regulation and state how those requirements will be satisfied (i.e. sets the structure for whats to be included on PMS Plan) and then a PMS Plan is, as you said, product specific where all of the required details are given