Hi, everyone!
What documents makes new rules on life cycle of AFI, ingredients and other substances?
All what I find:
-
EU GMP
EudraLex - Volume 4
Chapter 3
Chapter 5
Chapter 6
Annex 15
Annex 16
Q3C
Q3D
Q7
Q11
If I`m wrong, correct me, please!!!
If you know some else sources, you may write it on your comments.
One of trouble is toxicological “passport” for substances. This passport is like as a basis for toxicological evaluation for cleaning validation.
What information must contain this passport, and what documents regulate it?
For cleaning validation we must do toxicological evaluation. What criterias we must review?
All this questions and others interested more and more companies!
Sorry for my English. Sorry for possible oftop!
Kind Regards,
Alex Gorkaviy