2 replies to this topic

[Dublinr]

3.11.6 Traceability of test data and samples to production lots shall be maintained. What does this mean exactly? Is it asking to keep production samples for every lot produced? or is this record keeping of of test data for every lot?

[beautiophile]

Hi,

From interpretation guide:

Where testing is carried out off-line, it is essential that the site is able to identify the production batches of lots from which the testing samples have originated. This ensures that results are linked to the correct batches and assists the site in validating its ongoing product quality results.

 

 

 Is it asking to keep production samples for every lot produced?

Not exactly in case of the Clause, but you should. The Clause requires you to know which production lot the test samples were retrieved from.

 

 

 

is this record keeping of of test data for every lot?

Same as above. I just point out that a traceability test can start from a record, here is an external or QA (off-line) record, not always from a material or product or semi-product.

 

P/S: There a topic for BRC Packaging (former IoP) and you can post there instead.

Edited by beautiophile, 14 April 2021 - 01:26 AM.

[Dublinr]

That's how I understand it but not everyone in my company agree. Also thanks for the P/S