Bioequivalence and Bioavailability Forum

Dear Jan,

❝ the new BE guideline recommends the use of labels with a tear-off portion

The "old" guideline recommended it too...

❝ what information should be printed on this tear-off portion and what is the purpose of it?

The purpose of the label is to document that each subject received the product that had been packaged for him and to ensure there is no doubt in each period whether the subject got the test product or the reference product. I would say the following would be the minimum information:

• trial reference number
  
• subject number
  
• period number
  
• product identity (test or reference), possibly also the batch number and potency
  
• if more than one, the number of dose units (e.g. 2 tablets)

❝ How do you archive these tear-off labels?

The idea is to stick it on the CRF when you administer the product to the subject, in real time.

❝ And more generally, how do you pack the products individually for each subject? If they come from the sponsor packed in blisters, do you divide the blister with scissors to single units and put them into an envelope with an appropriate label? Or do you put the tablets from the blisters to a bottle?

I would suggest to keep it in the blister, divide the blister with scissors and put the single units into envelopes, bottles, containers or whatever you usually use.

Have a look at the Q&A published by EMA's GCP inspectors group, particularly regarding documentation requirements.

Regards
Ohlbe

Dear Jan,

cave scissors!
We always ask the sponsor to pack the IMPs individually (for each subject, for each period according to the RND list). By using scissors for dividing the blister you eliminate the rationale for the tear-off label.
One subject - one blister.

As Dr. Dan wrote - by any kind of manipulation with the IMPs you would need a GMP certificate.