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SOP for How to Write a Specification for Raw Materials and Finished Good
UL - Underwriters Laboratories - Health Sciences
SOP for How to Write a Specification for Raw Materials and Finished Good
SOP for How to Write a Specification for Raw Materials and Finished Good
SOP for How to Write a Specification for Raw Materials and Finished Good
SOP for How to Write a Specification for Raw Materials and Finished Good
SOP for How to Write a Specification for Raw Materials and Finished Good
SOP for How to Write a Specification for Raw Materials and Finished Good
SOP for How to Write a Specification for Raw Materials and Finished Good
SOP for How to Write a Specification for Raw Materials and Finished Good
SOP for How to Write a Specification for Raw Materials and Finished Good
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21 cfr part 820 - med. device mfger. qsr requirements, acceptance criteria, finished goods/products, iso 13485 - medical device qms, raw materials, sop (standard operating procedure), specification details, specifications (general term), test methods and procedures and plans
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  Post Number #1  
Old 5th February 2014, 11:22 AM
terry31575

 
 
Total Posts: 8
Please Help! SOP for How to Write a Specification for Raw Materials and Finished Good

I am building a FDA 820/ISO 13485 quality system. I am working on an SOP for how to write a specification for raw materials and finished good. Do I need to provide justification for each test and acceptance criteria that is listed on the specification?

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  Post Number #2  
Old 7th February 2014, 09:39 AM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 15,223
Re: SOP for How to Write a Specification for Raw Materials and Finished Good

A Quick Bump!

Can someone help?

Thank you very much!
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  Post Number #3  
Old 3rd March 2014, 02:33 PM
Meatgrinder

 
 
Total Posts: 11
Re: SOP for How to Write a Specification for Raw Materials and Finished Good

If you look at an audit check-list you may find your answer. I looked and found several questions related to acceptance criteria. Google ISO 13485 7.1q3 audit checklist. i.e.

In planning product realization, the organization shall determine the following, as appropriate:
a) quality objectives and requirements for the product;
b) the need to establish processes, documents, and provide resources specific to the product;
c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance;
d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4).

Not sure if this helps but if it does...I'm happy to have helped
  Post Number #4  
Old 3rd March 2014, 06:07 PM
Ronen E

 
 
Total Posts: 3,517
Re: SOP for How to Write a Specification for Raw Materials and Finished Good

Quote:
In Reply to Parent Post by terry31575 View Post

I am building a FDA 820/ISO 13485 quality system. I am working on an SOP for how to write a specification for raw materials and finished good. Do I need to provide justification for each test and acceptance criteria that is listed on the specification?
Hi,

I'm assuming you refer to testing in routine production (not R&D).

The justifications for such tests are developed during the R&D phase, and are translated into specifications and instructions that will be used in production, during the Design Transfer (actually, in some companies it begins in Design Validation). Hence, the requirements to document those justifications would - IMO - belong in your Design Control SOPs, and more specifically in the Design Validation and Design Transfer procedures. The justifications themselves belong (again, my opinion) in the DHF or it's 13485 equivalent.

Cheers,
Ronen.
Thanks to Ronen E for your informative Post and/or Attachment!
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