PSMF structure for clients

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    Sue Gandy

    As a technical consultancy providing PV and QPPV services to several clients we do not need to register a PSMF – I assume this is correct? However we manage several clients who are an MAH, who each hold a registered PSMF  and for whom we provide the QPPV and PV service. Question is how to describe the PV system in one document which is maintained by PV, overseen by the QPPV but which can be referenced  in each client PSMF? Could we hold a summary document, formatted as a PSMF with associated annexes,  whilst the MAH PSMF consists of a cover sheet and oversight description?  With the complications of Brexit scenarios we are looking to simplify processes to ensure compliance. I would be grateful for your comments. Thank you.


    Please note, that the response to your query represents the opinions formed from a consensus of the PIPA Committee, but do not represent their employing companies. These responses are intended as guidance. Please also refer to guidelines and your own company procedures. 

    Dear Member

    Thank you for your enquiry regarding the PSMF structure for clients.

    To respond to your first question, it is correct that you do not need to register a PSMF, this is the responsibility of the MAH.

    Regarding your second question, it is not recommended to have a central document for the service provider, referred to in each client PSMF. It would be good practice to have a template PSMF which is used for each client and therefore makes things consistent and easier to make updates across all clients, when required. The MHRA pilot of inspecting services providers found that it wasn’t appropriate, as each individual MAH PV system differed so much, even where the same service provider was being used ( Therefore, a central description of the service provider system is unlikely to be directly relevant to every client anyway.

    This was also discussed at the July PIPA LIVE PV Webinar and we would recommend referring back to that for additional input from other PIPA members.

    I do hope this is of help to you.

    Kind regards


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