4 replies to this topic

[pabloqa]

Hello All!

 

I would like to know if any of you could help me with this:

I am trying to write a Foreign Material Control Program for an operation that only consists of distribution of pre-packaged, shelf-stable food, let's say for example, seeds and oils in retail packaging. Operation is basically: receiving, storing and shipping. Nothing is re-packaged or re-processed.

Can foreign material be controlled by only conducting a visual inspection and verification of packaging integrity?

I understand Foreign Material controls are much more complex in case of manufacture, but I am trying to write a program only for a warehouse for finished products.

Thanks a lot!

[Charles.C]

Hello All!

 

I would like to know if any of you could help me with this:

I am trying to write a Foreign Material Control Program for an operation that only consists of distribution of pre-packaged, shelf-stable food, let's say for example, seeds and oils in retail packaging. Operation is basically: receiving, storing and shipping. Nothing is re-packaged or re-processed.

Can foreign material be controlled by only conducting a visual inspection and verification of packaging integrity?

I understand Foreign Material controls are much more complex in case of manufacture, but I am trying to write a program only for a warehouse for finished products.

Thanks a lot!

Hi pabloqa,

 

Is this for Canadian Consumption ?

 

Does the Scope of your "Foreign Material" include the Product ?. I assume Yes.

 

It sounds like you are more urgently in need of a Supplier(s) Approval program ?

[pabloqa]

Hi Charles C.

Yest, it is for Canadian consumption, specifically to establish a PCP. I work already with a Supplier Approval Program and evaluate suppliers on an annual basis, and in our questionnaire we make some questions about foreign material control, but I wanted to see if we need to have our own Foreign Material Control program too, as we do not manufacture the products.

Thank you very much for your comments and feedback, I appreciate it very much!

Pablo H.
 

Hi pabloqa,

 

Is this for Canadian Consumption ?

 

Does the Scope of your "Foreign Material" include the Product ?. I assume Yes.

 

It sounds like you are more urgently in need of a Supplier(s) Approval program ?

 

[Charles.C]

Hi Charles C.

Yest, it is for Canadian consumption, specifically to establish a PCP. I work already with a Supplier Approval Program and evaluate suppliers on an annual basis, and in our questionnaire we make some questions about foreign material control, but I wanted to see if we need to have our own Foreign Material Control program too, as we do not manufacture the products.

Thank you very much for your comments and feedback, I appreciate it very much!

Pablo H.
 

Hi Pablo,

 

From the POV of the (fully enclosed) Product, the risk from your environment is presumably limited to "Damage" which should hopefully be negligible if GMP requirements are maintained, eg as detailed in US cGMP Regulations. I anticipate there are equivalent Canadian requirements.

[pabloqa]

Hello Charles C.

Thank you very much for taking the time and responding so quickly.

 

Have a great weekend!

 

Hi Pablo,

 

From the POV of the (fully enclosed) Product, the risk from your environment is presumably limited to "Damage" which should hopefully be negligible if GMP requirements are maintained, eg as detailed in US cGMP Regulations. I anticipate there are equivalent Canadian requirements.