Revision of EU GMP Chapter 1 to enhance Quality Risk Management

According to the EMA's Work Plan for the GMP/GDP Inspectors Working Group for 2018, Chapter 1 of the EU-GMP Guidelines (Pharmaceutical Quality System) will be revised. The task is to "draft a proposal to amend the chapter in order to encourage industry adoption of risk-based approaches to prevention of shortages".

The document is also referring to the HMA/EMA Task force on availability of authorised medicines. If drug shortages are related to manufacturing or quality issues, will fall into the remit of EMA. The Agency has worked on how to best manage these shortages since 2012, resulting in the development of a comprehensive set of documents to support regulatory authorities in addressing shortage situations due to GMP non-compliance/quality defects. The task force is part of these activities.

One of these documents is the "Reflection paper on medicinal product supply shortages caused by manufacturing/Good Manufacturing Practice Compliance problems" (EMA/590745/2012). This reflection paper might give hints to what might be included in the revision of chapter 1. This paper for example refers to the increasing globalisation with extended manufacture and supply chains and its associated risks. It is mentioned that "industry's risk management tends to be very reactive rather than proactive" and that there is a need to bring "a change in a manufacturer's approach to quality risk management and supply chain security".

Source: EMA's Work plan for the GMP/GDP Inspectors Working Group for 2018