Guides and Ebooks

Making lighter work of finished product manufacturing site
transfer variations in life sciences.

Recognizing the needs of pharma supply chains.

Arriello is at the forefront of ICH Q12/PACMP-based finished product manufacturing site transfer variations management.

Over the two years to March 2023, we catered for up to 50 finished product manufacturing site transfer variations, both national and MRP applications, with submissions successfully performed across the EU and Eastern Europe deriving from our own experience the features of both the traditional and PACMP approaches. 

Here we had the opportunity to work with a range of pharmaceutical forms, and generic products, well-established use medications, as well as standalone applications.

Specific new measures under International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use guideline Q12 include the Post-Approval Change Management Protocol (PACMP).

The following guide looks more closely at the benefits of the new protocol, and what’s involved in using the new framework for post-approvals change management linked to finished product manufacturing sites.

Download full PDF to read more