GMP+ exceeding action limits

Hi all,

I am having a discussion within our team regarding the GMP+ norm ''Minimum requirements EWS'' (EWS=early warning system) and the decision tree.

GMP+ BA1 Minimum requirements EWS it reads:

''The participant is obliged to notify GMP+ International and the certification body in case of signals or perceived facts that a feed has a negative effect on the feed – and/or food safety, such as:
a. an exceeding of the maximum permitted level(s) of undesirable substances in feed as mentioned in legislation or/and GMP+ BA1 Specific feed safety limits, irrespective of the measurement uncertainty, or
b. other non-conformities or irregularities related to feed safety aspects (others than complaints), not controlled by the participant, which could have consequences for other companies.''

 

And within the guidance we can read:

 

''Informing customers In case the non-conforming feed has been delivered to customers, the participant should inform those customers. Examples of non-conformities or irregularities as mentioned under b:
a. Matters directly observable in the product (color, odor - for example a strong odor of petrol).
b. Analytical results falling outside standards or specifications (exceeding agreed action limits, standards or tolerances, or extremely high values in the absence of standards).
c. Signals or suspicions of increasing levels of undesirable substances in certain region. d. Abnormal illness/death of animals.
e. Unusual or inexplicable occurrences''

 

I read this meaning that we should notify GMP+, our CB and our customer if we exceed our action limit.
However my colleague disagrees that we do not have to notify regarding a action limit. What do you think?

For those unfamiliar with action limits example: we hold a rejection limit for dioxin on >0,75ng/kg, but we maintain a action limit >0,5ng/kg. Meaning that if we exceed 0,5 ng/kg we should investigate the rootcause and possible mitigation actions, but the product can still enter the market.
 

​In the event of exceeding the action limit: Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination.

 

so have you "exceeding agreed action limits," as per the standard?

is the >0,5ng/kg. an agreed upon level/limit?

The action limits are requirements from the GMP+ standard. All companies use the same action limits.
So in that sense I guess that they are agreed upon ?

We do btw always state these action limits in our certificate of analyses (COA) with each batch.
So we could also argue that we always inform our customers on any limits.

I think your both right

You're not above your limits for shipments. But you are above your target or "agreed upon" limits---the underlying caveat here is that your CB knows that you would still put that product to market

Always err on the side of caution--tell your CB

Or just ask them---that's what your paying them 1000s of $$ for