The final version of "ICH Guideline Q12 on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management" was published in January 2020. An integration of this guideline into the legal framework of the European Union, the implementation by the involved authorities and member states is still pending.
The ICH Q12 guideline sets the framework for the management of post-approval changes. The aim is to enable technical developments and, at the same time, to harmonize and effectively structure the regulatory requirements for changes throughout the entire lifecycle of medicinal products.
With the implementation of the ICH Q12 guideline, so-called "tools and enablers" are proposed. These are intended to enable uniform and facilitated management of licensing changes for all regulatory authorities and marketing authorization holders involved. While some of these tools have already been realized for the EU, other terms and the legal integration are not established in the valid legal framework of the EU (EUDRALEX).
The GMP Journal devotes attention to these instruments of the ICH Q12 Guideline, which are new for the pharmaceutical legislation of the EU, with an article by Dr. Martin Melzer, Principal Consultant at gempex GmbH:
ICH Q 12 Pharmaceutical Product Lifecycle Management
Concept and Implementation of the "Established Conditions (EC)"
and the "Product Lifecycle Management (PLCM)" Document.
These two new tools are discussed in the context of licensing and process validation. Established conditions are defined, compared in the EU and US jurisdictions, the two basic approaches to establishing ECs - parameter-based approach and performance-based approach - are presented, and the resulting PLCM document is considered. Aspects of a possible implementation in the EU regulatory framework for medicinal products are also discussed.
The article can be obtained via gempex.com/GMP-Knowledge .
Dr. Martin Melzer is available to answer technical questions.
Please address to contact@gempex.com