This presentation relates to Annex II.1 of ICH Q9(R1)
To ensure the adequate management of risks and continuous improvement, it is essential for the principles and practices of QRM to be fully integrated within the PQS as outlined by ICH Q9 (R1).
- • ICH Q9 (R1) is not a guidance document intended to stand alone and it should be considered together with the other ICH Quality Guidelines.
- • QRM is a valuable component of an effective pharmaceutical quality system and is a regulatory requirement