Import testing Contribution from Z Pawlak written on 10/3/2008 at 20:05
Import testing refers to a number of complete market finished packs being tested to full specification prior to QP certification and release by the MA holder in the EU. The import testing laboratory in the EU will normally not review the carton or leaflet of the product, and if the product is blistered is likely to only be interested in the batch number/expiry date prior to removing the product e.g tablets and testing them to full specification.
Are there any thoughts regarding the possibility of testing the primary pack (i.e the laboratory receives only blisters), on occasions, to speed up the lead time to certification and release by the MA holder - especially if for some reason the primary pack has to be stored for a month or so before cartoning (assume that there are no issues with stability etc). How does the QP stand on this along side the reasons why import testing is carried out in the first place?
Answers to this contribution:
Answering this Contribution:
|
