4 replies to this topic

[mtelander]

I work for a dietary supplement contract manufacturer and we are looking to finally implement a skip lot testing program for our raw materials (herbs, amino acids, vitamins, etc) but I am kind of stuck when it comes to writing the actual SOP. I have gotten with Quality Control and Analytical to get their feedback but would love some insight or maybe if anyone could share some examples of their skip lot testing SOP's?

[Scampi]

out of curiosity--why are you going this route?

[mtelander]

out of curiosity--why are you going this route?

We deal with over 3,000 raw materials and we test everything both in house and thrid party, so in order to help save on testing costs we wanted to implement a skip lot program for items that are low risk. So we perform risk mitigations on all of our raw materials and then if it is low risk we can look at the testing parameters and possibly put it on an annual skip lot program

[Scampi]

got it

 

Why not use the AQL method to determine the sampling plan on low risk materials (assuming the supplier is also low risk through your supplier approval program)

 

Then it would be based on risk AND volume purchases and/or how many FG said material is used in

[nwilson]

got it

 

Why not use the AQL method to determine the sampling plan on low risk materials (assuming the supplier is also low risk through your supplier approval program)

 

Then it would be based on risk AND volume purchases and/or how many FG said material is used in

 

100% agree with this, AQL is the best way to go.