The guidance is basically asking that you put a seal so that you can tell whether or not someone
opened it and did anything to the material under normal conditions. The answer, in my opinion, is
that’s fine. If you use unique tape and can tell if it had been opened, you’ve certainly satisfied the
intent of the guidance.
Any measure you can take to ensure the integrity of that material while it’s in transport is most
beneficial to you and to your clients. There are many ways of doing that, not only of using seals
that have specific designs, which may be hard but may not be impossible to imitate. Some
companies use some kind of markings that, under normal lighting are not visible, and are only
visible under UV lighting or special lighting conditions to mark containers. The persons receiving
this material know that if they look for those markings in specific locations with special lighting, if
it’s missing, that’s usually an indicator that that’s not their original material.
Don’t forget that the Agency is very concerned about the potential for counterfeit APIs. So,
obviously, if you make it difficult for somebody to hide a change in the material, you make it much
more difficult to put something else into your box or your container.
