Is Site Master File necessary for a European Medical Device Manufacturer (class III)?

C

Cosma

#1
Hi folks,

working for a medical device manufacturer (class III) in Europe with focus on FDA-market, I want to know if there is something like a Site Master File necessary for medical device industry.

I´ve been doing Quality Management for pharmaceutical industry for several years and there a Site Master File is a basic element. It is a more or less detailed description of the firm, its manufactured products, materials, processes, equipment, personnel, sales, etc.

Now doing QM for medical devices, i wonder if there is something similar for MD because I found it very useful and it was handed out to notified bodies or other inspectors to give a "global overview".

Can anybody tell me, if I need a Site Master File in medical device industry?And where is the corresponding requirement (FDA, DIN EN ISO, etc.)?

Thank´s a lot
Cosma
 
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Ajit Basrur

Staff member
Admin
#2
Re: Site Master File

I do not think Site Master File is required for Medical devices - its definitely required for manufacturing sites supporting Pharmaceuticals.

I am attaching a link to the PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME (PIC/S) document on Preparation of a Site Master File . In this document, section 2.1 clearly states the following -

The Site Master File is prepared by the manufacturer and contains specific
information about the quality assurance, the production and/or quality control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceutical operation is carried out on the site, a Site Master File need only describe those operations, e.g. analysis, packaging, etc.

Even the MHRA - Preparation of SMF refers to Pharmaceuticals only.
 
G

Gert Sorensen

#3
Re: Is Site Master File necessary for a European Medical Device Manufacturer (class I

It is not a requirement, but it may come in handy in MD-companies with multiple sites.
:bigwave:
 
J

Jimmy the Brit

#4
Re: Is Site Master File necessary for a European Medical Device Manufacturer (class I

working for a medical device manufacturer (class III) in Europe with focus on FDA-market, I want to know if there is something like a Site Master File necessary for medical device industry.
Hi Cosma,

The nearest I have found to a SMF in medical devices is the Site Quality Plan required by the USFDA QSR's (21CFR820.20(d))
Quality planning: Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met
which isn't massively dissimilar to a SMF. I like having either a SMF or a SQP because it is a useful reference source for the site and it helps internal auditor get up to speed with the site level QMS.

Jimmy
 
S

SAM SAMIRA101

#5
Re: Is Site Master File necessary for a European Medical Device Manufacturer (class I

yes master file is required
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#6
Re: Is Site Master File necessary for a European Medical Device Manufacturer (class I

Sam - Can you cite what document (or regulation or whatever) requires one?
 
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