The European Union has released the new (and very much anticipated) GMP Annex 1 revision after 14 years of development!

The GMP Annex 1 has all the manufacturing requirements sterile drugs both made in the EU and imported products. This 2022 version presents an upgrade to 59 pages from the original 16 covering the following topics:

  • Design and control of facilities
  • Pharmaceutical Quality System (PQS)
  • Equipment
  • Systems
  • Procedures

A special focus on QRM

The scope of the annex makes it very clear about the importance of QRM:

This Annex provides general guidance that should be used in the design and control of facilities, equipment, systems and procedures used for the manufacture of all sterile products applying the principles of Quality Risk Management (QRM), to ensure that microbial, particulate and endotoxin/pyrogen contamination is prevented in the final product.

In fact, the update stresses that an effective risk management system needs to be integrated into all areas of product lifecycle.

Which, in turn, takes us to the next point on how to apply the GMP Annex 1 Revision.

Integrating QRM over product lifecycle

The implementation of a QRM system over the lifecycle is not as simple as it sounds.

And even then, once end-to-end risk-assessment is completed, a lifecycle management plan should be put into place. This will help managing both product and any associated risks which are not necessarily connected to manufacturing.

ICH Q9 tells us that managing any unusual situation in the LCM or QRM contexts requires:

  • Risk Identification
  • Risk Analysis
  • Evaluation
  • Control

Risk Identification and Analysis requires effective knowledge capture, process mapping and the definition of unit operations with specific attributes.

This implies, firstly, to identify, to understand, to quantify and to rank risks as well as being able to formulate risk control strategies.

Then, the next steps are:

  • Managing unacceptable risks,
  • Evaluating the control strategy performance,
  • Detecting improvement opportunities,
  • Managing additional risks originated from new events (e.g., post approval changes).

So, how can we streamline this process? How can we apply the principles of QRM throughout the Lifecycle in accordance with the GMP revision?

The answer is: through Digitalisation of Quality Risk Management.

Digitalising Quality Risk Management

When we talk about Quality Risk Management Digitalisation we mean the departure of the Excel-based, silo-divided routine where a historic is not kept and where compliance depends on more variables than it should.

Once you reach it, you will unlock several meaningful benefits that impact business and mission-critical goals such as:

  • Connecting and comparing data across your whole organization, not just your facility or department.
  • Working together whether you are in the same building or in a different continent.
  • Making informed choices about compared risks.
  • Evaluating how the actions that you are planning to take will affect the status of an identified risk.

We can help you fulfil the GMP Annex 1 requirements

These revised requirements will become mandatory and take effect on the 25th of August 2023.

Until then, there’s time for you to implement a Digital QRM System that guarantees your compliance over the lifecycle.

With our risk management platform and our senior experts, our team can assist you to identify, quantify, and prioritise risks for a robust business continuity plan!

If you want to know more about our services, check out our page and don’t hesitate to reach out!

More on QRM Digitalisation

If you’d like to know more about QRM Digitalisation, check our publication about Quality Risk Management over the Lifecycle.