The 2020 release of the EU GMP Annex 1 draft includes a new chapter on viable and non-viable environmental and process monitoring. Trend analysis and its impact on the contamination control strategy is now an essential activity that is referenced multiple times. There is also clear differentiation between qualification and monitoring, and quality risk management concepts are interwoven into each section.
In the Principle section (Section 2), the guidelines indicate risk assessments should be performed for each area to ensure they are optimized, validated and qualified. Quality objectives are set and fulfilled through the implementation of quality assurance (QA) systems. These systems are controlled via scientific evaluation of risks in accordance with Quality Risk Management (QRM) principles. Monitoring devices provide the reliable, actionable data necessary to support scientific evaluation, and are best utilized as part of a network of fail safes to prevent unforeseen events (i.e., interventions, system deterioration) from impacting product quality.
There are no assumptions when determining risk. All decisions and methodology must be justified in a document called the contamination control strategy (CCS), referred to multiple times throughout Annex 1. The CCS should be an active document at all times for its continuous improvement and application.
Per the new guidance, there are 3 core events to establish environmental contamination control in a clean area. In order to understand when and where they occur, they must be differentiated based on purpose.
- Monitoring, where the potential contamination risk to your product is assessed is the first and most obvious. This can include additional testing outside of manufacturing areas and operations to identify areas where contamination could be allowed into clean areas. But how are clean areas designated as such?
- This is the role of qualification, where a classified room’s compliance with its intended use is determined. Qualification must be performed every 6 months for Grade A and Grade B, and every 12 months for Grade C and Grade D.
- Classification is where the intended use or “cleanliness” of a room is determined, based on ISO 14644-1:2015 regulatory specifications. Classification is a step within qualification and employs the use of monitoring equipment to determine relevant total particle counts for comparison. Refer to EU GMP Annex 15 for the methodology, and ISO 14644-3:2019 for the steps for testing.
The new guidance goes into much more detail on each of these topics and more:
- System Design and Monitoring
- Settle plates and Single use microbial monitoring
- Cleaning and Disinfection
- Risk Assessment
- Events and Deviations
Particle Measuring Systems has complete cleanroom contamination control solutions to help you meet EU GMP including:
- Our Contamination Control Advisory Services who can conduct an expert Risk Assessment for your pharmaceutical processes
- PMS cleanroom particle counters including portable/mobile and fixed/remote
- Microbial monitors including portable/mobile, fixed/remote, and single use.
- Data management software from Particle Measuring Systems
- Customizable, turnkey Facility Monitoring Systems (FMS)