Clean rooms are at the heart of the manufacturing of pharmaceuticals, medical devices, in-vitro diagnostic solutions and electronics. Each manufacturer makes a commitment to the patient/customer to produce quality products that are safe and effective. Environmental monitoring (EM) plays a significant role in achieving this goal as it provides critical information about the manufacturing environment. It’s how a manufacturer can demonstrate that their manufacturing process is under control.
It should therefore come as no surprise that there are many regulatory requirements and guidelines surrounding EM activities. If we look at pharmaceuticals in particular, the regulations, like the EU’s Annex 1 GMP guideline, are continuing to change and have become stricter and more rigorous.
Why is this the case?
If we look at some recent drug product recalls or regulatory citations, we will see many caused by the contamination of sterile products. We can conclude that this is a very real and current problem in the industry.
What are the regulators looking for?
Quite simply, if something were to go wrong, then the site should be able to predict it in advance, or at the very least, prevent it from happening again if it does occur.
How can a site ensure that they’re complying with the asks?
Quality Risk Management (QRM) is fundamental in all processes and an EM program is no different. Especially considering its part in demonstrating the level of controls in place for risks that are identified in the Contamination Control Strategy (CCS). Data from our EM becomes a powerful tool when we move away from looking at individual data points and evaluate our data, looking for trends that could be an early indication of a looming loss of control. It can put a site in a position where they can respond positively, and most important, prevent incidents from occurring.
What is a good risk assessment?
This risk assessment is not intended to be a one-time activity but should be regularly reviewed. This isn’t a small task, I know, and because of that, it’s often overlooked. But it’s expected that there is a periodic review of the EM program, otherwise one cannot demonstrate its continued effectiveness at detecting contamination.
What questions can be considered (continuously!)?
- Do we have any new risks associated with my EM Program?
- Can I see that my EM program is fully capable of detecting contamination? Are there new areas for microbial ingress?
- Have we had any changes to the EM program, and if so, do they introduce any new risk?
- Have there been any changes in current manufacturing operations and procedures? Is my sampling plan still relevant?
- Is my EM program guided by accurate, scientific microbiological principles?
- Are my EM methods modern? Scientifically sound? Are there new developments/systems that would be beneficial to implement?
- Am I reviewing my EM data in a way that is meaningful? Is my data allowing me to make operational decisions with appropriate justification?
- Is the frequency of my review appropriate? Does it allow me to trend and predict sufficiently?
- Is my data accurate and reliable? If not, my data analysis cannot be sound.
Begin with the end in mind!
An EM Program is designed as an early warning surveillance system. Any risk to an EM program means added risk to the final product. Therefore, evaluating the effectiveness and integrity of a program on a routine basis is essential. Also, a site should trend EM data to look for areas that can be better controlled. In the end, the effort applied results in better compliance, increased quality, and improved patient safety.
At No deviation, we provide environmental monitoring solutions for pharma manufacturing through our partnership with Mirrhia. You can read our article on Mirrhia – an environmental monitoring system for the pharma industry, to learn more about this solution and its benefits.
With over 20 years of international experience across the pharmaceutical and medical device industry, predominantly in Project Management, CQV, Tech Transfer, Regulatory and Quality/Compliance roles, Evelyn has held both Consultant and End User roles. As an experienced Lead Auditor, she provides value in end-to-end solutions across the lifecycle of project delivery.