The EU GMP Annex 1 on “Manufacture of Sterile Medicinal Products” has finally been revised and published after several years.
This new regulation states that its aim is: “provide 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.”
With that in mind, let’s look at the change that most impacts our day-to-day activity.
The Contamination Control Strategy (CCS): is a planned set of controls to reduce and control the concentration of micro-organisms, endotoxins/pyrogens and particulates.
For these we must define all critical control points and evaluate the effectiveness of all controls for our process and define or re-evaluate the monitoring measures used to manage the risks associated with contamination.
To meet the requirements of the standard and ensure control of particulate and microbiological contamination, we must make use of QRM in establishing our CCS.
What is CCS and how does it impact us?
This Contamination Control Strategy (CCS) is a living document, which we will need to include within our quality assurance system and must be periodically reviewed and evaluated according to the impact of changes made.
How do we develop this document?
Let’s take a closer look at what the steps would be to design our Control Contamination Strategy:
Which stages of my process should I assess?
When carrying out the RA, we should base our assessment on data from the following stages of our process:
We must not lose sight of the possible sources of contamination in our assessment of these stages, hence the importance of collecting all the information for each stage. For example:
Let’s see how we could determine the possible sources of contamination of a Production Process using the Ishikawa Diagram.
We will assess whether each of the points selected could be a source of contamination.
The other major change in Annex 1 is in the PQS (Pharmaceutical Quality System), based on ICHQ10. Specifically, this system must ensure the following: