Course overview
ICH Q12 provides a harmonised framework for management of post approval CMC changes more predictably and efficiently across the commercial lifecycle, using risk and science-based approaches and an effective Pharmaceutical Quality System (PQS).
The guideline introduces a set of practical tools and enablers, including risk-based categorisation of changes, Established Conditions (ECs), Post Approval Change Management Protocols (PACMPs), and the Product Lifecycle Management (PLCM) document, and explains how these connect to regulatory assessment and inspection expectations.
This course translates Q12 into real-world execution for the delegates and explains to them how to define ECs without ‘over locking’ the dossier, how to set reporting categories based on risk and knowledge, how to design PACMPs that regulators can approve, and how to keep lifecycle documentation inspection ready while enabling continual improvement.
CPD Hours: 12
Course Content
- Day 1
- Why ICH Q12 matters: mindset for marketed products
- ICH Q12 overview and key concepts
- Risk-based categorisation of post-approval CMC changes
- Established conditions (ECs): defining the flexible regulatory controls
- ECs in manufacturing: process performance and lifecycle controls
- ECs for analytical procedures
- Day 2
- Post-approval change management protocols (PACMPs) - designing effective protocols
- PACMP: execution, reporting, and common pitfalls and knowledge management
- Product lifecycle management (PCLM) document
- Managing frequent changes and ‘immediate notification’ scenarios
- Supply chain strategy and regulatory communication
- Stability data and post approval changes
Speakers
Paul Palmer
Paul R Palmer is a Director / Pharmaceutical Consultant and a practicing EU / UK Qualified Person. He has over 35 years experience in the pharmaceutical industry in the development, manufacture and supply of medicinal products and medical devices.
Throughout his career, Paul has intentionally taken on all opportunities as they arose in order to develop a broad range of knowledge with an in-depth detailed understanding of manufacturing, storage, distribution, research, computerised systems, as well as the facilities and services to support each.
People and systems have always been a core focus, how to ensure best use, optimise and enhance efficiency. He has a level of curiosity rarely displayed in people taking on the qualified person role in pharmaceutical manufacturing. Culture, behaviour and psychology are all significant influences on the systems and processes we implement, but are often ignored.
Paul studied psychology as part of his MSc in 1993 and has always enjoyed observing the world around him with a curiosity that is rarely satisfied.
