21st September 2022 Content supplied by: Microgenetics
Adapting Your EM Plan for Annex 1: What you Need to Consider
The long-awaited revision of Annex 1 has finally been completed, ready to come into operation in August 2023. Introduced to prevent contamination in your final product, the updates include many clarifications and additional instructions for sterile manufacturers to consider. So, what does this mean for your environmental monitoring?
The environmental monitoring programme
Your EM programme is a significant aspect of the contamination control strategy. Annex 1 requires a written sampling plan for your environmental monitoring, and that your contamination control strategy should directly influence your EM programme. Your plan should allow for meaningful data, providing assurance that cleanrooms are appropriately clean and that you are able to detect excursions which may provide a risk to product quality.
Now that the final revision of Annex 1 has been released, it is important to review your environmental monitoring programme to make sure the methods being used are still compliant.
Where to begin
You'll need to start by auditing your EM processes. That way, you can understand which methods you are currently using, why, and what sort of data is being produced. Especially with newer sections such as utilities, your audit will be an important step.
Make sure you look at both viable and total particle contamination, pressure differentials, temperature and humidity, and airflow. Ensuring a complete data set is important for assurance of the aseptic condition of your facility. Consider how well your current systems work for this, and how well it will detect when you have contamination.
When documenting your new environmental monitoring programme, you must consider all areas of your operations, from initial manufacture of raw materials and components to the final product filling and finishing procedures. Monitoring of surfaces, air (using passive and active air sampling), compressed gasses and personnel should be documented, and you should understand the consequences of non-compliance.
Evaluating your EM data: trending
It’s important to understand how well your containment strategies are working. Your environmental monitoring programme should therefore include consideration of results generated from your environmental monitoring. This includes:
- Trend analysis of your results
- Analysis of organisms recovered in your facility
- An understanding of the source and routes of contamination
All environmental monitoring data for classified areas in your cleanrooms should be reviewed as part of batch certification, but also reviewed regularly outside of manufacture to confirm control.
Within your environmental monitoring programme, document the actions to be taken if any limits are exceeded, or emerging trends are detected. In this instance, root cause investigations should be performed, and an assessment of the potential impact to the product should be performed.
Corrective/preventative actions should also be detailed. It is important to perform investigation on the impact of any batched produced between the monitoring and reporting, not just of the batches manufactured during monitoring.
If alert limits are exceeded, assessment and follow up should be documented. This should consider whether additional investigation or corrective/preventative actions may be required to prevent further deterioration of the environment.
Annex 1 states that “particular attention should be given to organisms recovered that may indicate a loss of control, deterioration in cleanliness or organisms that may be difficult to control”. This means that, as well as performing identification from any isolates in your grade A and B monitoring, periodic review of isolates recovered in your grade C and D areas should also be performed. An idea of the “normal” flora in these areas will allow you to then detect if any changes to this norm are occurring.
You also need to review your environmental monitoring programme to make sure you are getting useful and accurate data, and make sure any new changes in regulation are captured as well. Updates may be required to drive continuous improvement to the manufacturing and control methods, and its effectiveness should be assessed periodically.
Tools that can help
With changing regulations comes plenty of stress and uncertainty. You want to be confident in your compliance, whilst ensuring productivity remains high. Therefore, Annex 1 will provide you with an opportunity to review new tools that can help you to streamline processes and meet regulation.
When it comes to your environmental monitoring, software solution SmartControl EM can help:.
- Built in line with GMP Annex 11 and FDA 21 CFR Part 11 & updates with any changes
- Paperless, removing data integrity issues around using paper and spreadsheets
- Reporting & analysis tools, plus instant trend and limit breach notifications so you can act sooner
Date Published: 21st September 2022
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