New toxicology data changes the health-based exposure limit for a product made in a shared facility. The recalculated cleaning limit is tighter than the validated analytical method can detect.
Step-by-step process flow:
The agent
Recalculates the limits from the approved inputs and compares them with the method's validated detection capability.
Release, certify or disposition a batch
Close a deviation, investigation or CAPA
File anything with an authority
Write to your systems outside the transitions you approve
Send a message without a named person's approval
Contact a regulatory authority or a customer
Promote itself to a higher autonomy level
Make you compliant. Compliance decisions and accountability stay with you.
REVIEW AND REGULATION
The reviewer sees
The calculation for a toxicologist to approve. The agent never changes a limit or a method.
Regulation
EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities; EudraLex Volume 4, Annex 15.
What does the agent do for a cleaning limit the validated method can no longer detect?
The agent recalculates the limits from the approved inputs and compares them with the method's validated detection capability.
What does the reviewer see?
The calculation for a toxicologist to approve. The agent never changes a limit or a method.
Does the agent make the decision?
No. The agent prepares the finding and a named person decides. The agent never releases, certifies or dispositions a batch, never closes a deviation, investigation or CAPA, and never files anything with an authority.
Which regulations apply?
EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities; EudraLex Volume 4, Annex 15.
Send an export for one batch or lot and see the workspace run on your own data.
