Reagent Status Identification - 7.4.3 Verification of Purchased Product

[Mandy]

We are a small R&D company developing an LDT, that we hope one day to market. We are in the process of becoming ISO 13485 compliant.

My question is regarding reagents:
The ISO Standard stipulates:
7.4.3 Verification of purchased product
The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.

I have not seen in ISO 13485 a requirement to identify (label) the status of reagents after receipt inspection.

When I worked in pharmaceuticals all raw materials were labeled with their status (quarantine, approved, rejected).
Is this necessary in such a small company that I'm currently working in?Reagents are not tested before use, we fill in a Receipt Inspection form, and I think that is sufficient.

Responses .....

 

[Mandy]

Hi
Since I got no responses, I thought I'd give my post a bump.
Hoping to hear from you.
Thanks
Mandy

 

[Ronen E]

From ISO 13485:2003

7.5.3.3 Status identification
The organization shall identify the product status with respect to monitoring and measurement requirements.
The identification of product status shall be maintained throughout production, storage, installation and servicing of the product to ensure that only product that has passed the required inspections and tests (or released under an authorized concession) is dispatched, used or installed.

(Emphasis is mine)

Cheers,
Ronen.

 

[Mandy]

Thanks for your response.
My question relates to the reagents used to create the product.
Do these need to be identified (for example with green/yellow/red labels)?
Again - we don't test any reagents before use, but rely on the COC.
Thanks

 

[somashekar]

Thanks for your response.
My question relates to the reagents used to create the product.
Do these need to be identified (for example with green/yellow/red labels)?
Again - we don't test any reagents before use, but rely on the COC.
Thanks

To test or not is your call. If the CoC verification is good for you, its fine.
The reagents are perhaps identified by the distinct name on the label itself. This will serve as your identification. There is no need of any color label.
How are the reagents stored and handled up to the point of use ?
How are the shelf life of the reagents known at the point of use ?
Is there a chance that a wrong reagent or an expired reagent will be used for the lack of its proper identification ?
Your answers to this must set up your identification method.

 

[Ronen E]

Thanks for your response.
My question relates to the reagents used to create the product.
Do these need to be identified (for example with green/yellow/red labels)?
Again - we don't test any reagents before use, but rely on the COC.
Thanks

S. 7.5.3.3 is usually interpreted to apply to components / ingredients of the product too (i.e. intermediate stages in creating the finished product). If your reagents are ingredients of the product (i.e. remain in some part and form in your finished product) then their status should be identified along the production process, IMO. If they only catalyze some reactions then perhaps they should be looked at as tools.

 

[Ajit Basrur]

We are a small R&D company developing an LDT, that we hope one day to market. We are in the process of becoming ISO 13485 compliant.

My question is regarding reagents:
The ISO Standard stipulates:
7.4.3 Verification of purchased product
The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.

I have not seen in ISO 13485 a requirement to identify (label) the status of reagents after receipt inspection.

When I worked in pharmaceuticals all raw materials were labeled with their status (quarantine, approved, rejected).
Is this necessary in such a small company that I'm currently working in?Reagents are not tested before use, we fill in a Receipt Inspection form, and I think that is sufficient.

Responses .....

Yes, it is required to label all reagents to ensure that expired reagents are not used. Its upto your organization to address this requirement either by use of colored labels or used of bar code labels etc.

Following quality systems is irrespective of the size of the company and thus though you are a "small" company, you have to follow the standard requirements.