Standards

All,


This is my very first post so I apologize in advance if this is not the correct forum for this type of question.  I've recently taken over our Incoming Quality group and I'm looking to do some streamlining and process improvements in the area.  What I'm wondering is if there are any pharma companies out there that have successfully implemented programs in which they have leveraged supplier quality to drastically reduce sampling and inspection especially when receiving multiple shipments of one vendor lot of a component.  I know that CFR requires that at least an identification needs to be performed on the components received for each lot of each shipment but I was curious if anyone has implemented a very minimal approach that is "passing" FDA and other regulatory agency muster.


Thanks,

K. Anderson

Like everything, this is a real “it depends”


A robust supplier management system is going to do two things, categorize the supplier based on audit and history AND categorize the material based on nature and use. Both are risk based. 


Once these are set up you can really reduce testing till it’s nothing more a visual confirmation for certain materials and certain suppliers. 


I recommend heading over to the Food, Drug and Cosmetic division community and asking this, we can get into all the geeky aspects of product contact and fit for use and the Q trio requirements and whether you are advanced biological or small molecule, and the such.


 

Will do!  Thanks Jeremiah

Hi Krista - Welcome to myASQ & thanks for posting!  this is a great group that I'm sure will offer more advice & helpful solutions for you. Thanks Jeremiah Genest‍ for jumping in to help!  

Let us know if you need any more help on this

Trish 

Hello Jeremia,

Can you elaborate what you mean by "categorize the material based on nature and use".

Thanks

I wrote more on this over at the FDC Community page, including breaking down categories: https://my.asq.org/communities/discuss/viewtopic/172/318/2388?post_id=7329#p7329