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Compliance Case Study #19. Primary Container Problems
GXP ✦ 01.20.2022
“Compliance Case Studies” (CCS) provides a forum for compliance practitioners to share information about actual compliance experiences. Previous discussions addressed a wide range of compliance activities. Previous case study titles discussed in this series include the following:
ICH Q9(R1) Quality Risk Management Revision – Public Consultation
JVT ✦ 12.23.2021
Revision of the ICH Q9 Quality Risk Management (QRM) guideline was released for public comment in December 2021. In the EU, the public consultation period begins on mid December and will continue for 3 months. ICH Q9 is a key guideline associated with risk-based change management and validation. The original version of ICH Q9 was issued more than 15 years ago; this is its first revision.
