February 21st, 2007

ONOZ

Ho. Ly. Crap.

Legend: my company is Lab A, the other company is Lab B and the client is Client (obviously). FDA/cGMP regulations apply here.

Lab A is doing stability studies for Client lots currently using in human clinical trials. Lab A does almost all of the testing, but some of the testing is being done by Lab B. Lab A has all of the sample and therefore needs to ship samples to Lab B. Otherwise, Client handles all of Lab B's work (payment, reports, ect. are sent to and from Lab B and Client directly). Recently, Lab B tells Client that Lab A did not ship enough sample. Client relays this to Lab A. Lab A tells Client that one bottle of each sample was shipped at this and the prior time points. Lab A provides copies of shipping paperwork and notebook copies showing sample amounts for the study confirming this. All bottles contain 3 +- 0.3g*. Lab B says they need 4.5g to complete testing. Client asks Lab B to send notebook copies and reports from prior time points. Lab B waffles for several weeks, then gives in. The notebook does not contain weigh tapes, but states that 3.75g of samples was weighed out for testing. Client suspects that Lab B was dry labbing the results, is trying to hunt down to original analyst (whose current status with Lab B is unknown) and will be sending auditors in the next few days.

The lesson here: Don't dry lab. If you are not dry labbing, make sure your records can prove that.

*Sample amounts changed to protect the not-so-innocent.