Science vs. standardization: justification vs. blind following of rules. New auditors’ expectations of a cleanroom monitoring plan

Annex 1 requires the development of an effective Contamination Control Strategy (CCS) based on a scientific assessment to understand the process and apply risk management principles . In the latest draft of Annex 1, the terms “risk”, “justification” and “strategy” are used frequently, underlining the importance of these concepts. It is critical for pharmaceutical manufacturers to understand this new approach.

Below, Particle Measuring Systems (PMS) experts discuss relevant areas of Annex 1 (4.1, 4.32, 9.6, 9.21, 9.24, 9.29, 9.33, 9T.38, 9.45), providing insights and highlighting key considerations when creating a contamination control strategy .

Contamination control strategy: risk, justification, strategy

The first indication of what regulators consider important for your cleanroom monitoring plan comes from the wording of the new draft Annex 1 compared to the current Annex 1. Not only is the word risk mentioned much more often than before, but so is the request to justify a decision and define a strategy. As far as strategy is concerned, a large part of the topics relate to a Contamination Control Strategy (CCS) .

*Includes 42 specific references to the Contamination Control Strategy (CCS).

Similar recommendations are described to justify sampling procedures for monitoring aseptic areas. Microbial monitoring of aseptic areas should be established using a combination of methods. The methods chosen must be the result of a scientific assessment, including the assessment of recovery efficiency.

9.24 Where aseptic procedures are carried out, microbial monitoring should often be carried out using a combination of methods such as swab plates, volumetric air sampling, glove, gown and surface sampling (e.g. swabs and contact plates).

 The sampling method used should be justified within the framework of the CCS….

9.29 The recovery efficiency of the chosen sampling methods should be qualified.

 

Microbial Monitoring and Your Contamination Control Strategy (CCS)

Not only is an environmental monitoring plan mentioned as part of a contamination control strategy (CCS), but also for microbial monitoring of staff and aseptic areas. In fact, the frequency of microbial monitoring of workwear should be based on scientific principles and justified as part of the CCS. To meet these expectations, monitoring points on aseptic clothing should be established as part of a quality risk management approach .

The new approach developed with the revision of Annex 1 promotes understanding of the processes and scientific assessment to justify any decision for a critical environmental monitoring plan in process control. Neither standardizing processes nor blindly following rules is the best approach to meeting auditors’ expectations.

9.33 Microbial monitoring of personnel in the Grade A zone and Grade B area should be carried out to assess their aseptic behavior. For manual filling processes, e.g. B. in hand filling, the entire process can be viewed as a critical intervention. In these cases, the frequency of microbial monitoring of the lining should be based on scientific principles and justified as part of the CCS.

In accordance with the recommendations, the method for detecting microbial contamination should be scientifically justified to ensure that contamination is detectable. The incubation conditions for the samples taken during production should also be scientifically justified.

9.38 The method for detecting microbial contamination should be scientifically based to ensure that any contamination is detectable.

 9.45 Filled APS units should be incubated in a clear container to ensure visual evidence of microbial growth. … The selection of incubation conditions and duration should be scientifically justified and validated to ensure an appropriate level of sensitivity for detecting microbial contamination.

In summary, the key takeaways from the draft Annex 1 are as follows:

 

• Process understanding
• Assessment of risks
• Contamination control strategy

In other words, when the examiner comes, you have to answer the key question “Why?” have an answer ready.

Contact us to have our Contamination Control team assist you in creating a Contamination Control Strategy (CCS) based on a scientific assessment.

Find out about our particle counters and viable particle monitors for your cleanroom needs to meet regulatory requirements such as Annex 1.

 

 

Particle Measuring Systems offers  complete cleanroom contamination control solutions to help you comply with EU GMP, including:

• Our  contamination control consulting services that can provide an expert risk assessment for your pharmaceutical processes
• PMS cleanroom particle counter  including  portable/mobile  and  fixed/remote
• Airborne germ monitors  including  portable/mobile ,  fixed/remote  and  single use .
• Data management software  from Particle Measuring Systems
• Customizable, turnkey  Facility Monitoring Systems (FMS)

More EU GMP Annex 1 information