Module 3 - Strategic case studies in practice

ICH Q12 Guideline

Term

Definition

MAH

Marketing Authorisation Holder

Notification

A change to an approved established condition that does not require approval prior to implementation. Post-Approval Change Management Protocol

PACMP

PLCM Product Lifecycle Management Post-approval CMC commitment Commitment by the MAH to undertake specific CMC activities to be implemented during the commercial phase. Prior approval

Change to an approved established condition that requires regulatory review and approval prior to implementation Product Quality Review – regular periodic review of API or drug products with the objective to verify process consistency, to highlight any trends and to identify product and process improvements

PQR

PQS

Pharmaceutical Quality System Quality Risk Management

QRM

Submission

Communication to a regulatory authority regarding a change to an established condition that could be prior approval or notification.

11 R EFERENCES ICH M4: The CTD -- Quality

ICH Q1A(R2) Stability Testing of New Drug Substances and Products ICH Q2(R1) Validation of Analytical Procedures: Text and Methodology ICH Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process ICH Q8(R2) Pharmaceutical Development ICH Q9 Quality Risk Management ICH Q10 Pharmaceutical Quality System ICH Q11 Development and Manufacture of Drug Substances ICH Q8, Q9, and Q10 Questions and Answers ICH Q8, Q9, &Q10 Questions and Answers -- Appendix: Q&As from Training Sessions (Q8, Q9, & Q10 Points to Consider)

23