Science vs standardization: justification vs blindly following rules. The new auditors’ expectations
Annex 1 requires designing an effective contamination control strategy (CCS) based on a scientific assessment to understand the process and to apply risk management principles. The latest Annex 1 draft frequently uses the terms “risk” “justify” and “strategy”, underlying the importance of these concepts.
Here we discuss relevant Annex 1 areas (4.1, 4.32, 9.6, 9.21, 9.24, 9.29, 9.33, 9T.38, 9.45), providing insights and highlighting important considerations when creating a contamination control strategy.
The first clue we get in the latest Annex 1 draft around what the regulatory authorities find important is from the choice of words used now compared to the current Annex 1. Not only is the word risk mentioned many more times than before, but also the request to justify a choice and to define a strategy. Concerning strategy, a significant portion of the topics is regarding a contamination control strategy (CCS). 
* Including 42 specific citations of Contamination Control Strategy (CCS).
Similar recommendations are described to justify sampling methods to monitor aseptic areas. Microbial monitoring of aseptic areas should be defined using a combination of methods. The chosen methods must be the result of scientific evaluation including the evaluation of the recovery efficiency.
9.24 Where aseptic operations are performed, microbial monitoring should be frequent using a combination of methods such as settle plates, volumetric air sampling, glove, gown and surface sampling (e.g. swabs and contact plates).
The method of sampling used should be justified within the CCS ….
9.29 The recovery efficiency of the sampling methods chosen should be qualified.
Not only is environmental monitoring mentioned as part of a Contamination Control Strategy (CCS), but also for the microbial monitoring of personnel and aseptic areas. In fact, the frequency of microbial monitoring for gowning should be based on scientific principles and justified as part of the CCS. To meet these expectations, the monitoring points on aseptic garments should be defined in a quality risk management approach.
The new approach designed by the Annex 1 revision, strongly encourages process understanding and a scientific assessment to justify every critical choice in process control. Neither standardization of processes nor a blind following of the rules is the best approach to meet auditor’s expectations.
9.33 Microbial monitoring of personnel in the Grade A zone and Grade B area should be performed to assess their aseptic behavior. Where filling operations are manual in nature e.g. hand filling, the process in its entirety may be considered as one critical intervention. In these cases, the frequency of microbial monitoring of gowning should be based on scientific principles and justified as part of the CCS.
In accordance with the recommendations, the method of detection of microbial contamination should be scientifically justified to ensure that contamination is detectable. Also, the incubation conditions of samples collected during manufacturing should be scientifically justified.
9.38 The method of detection of microbial contamination should be scientifically justified to ensure that any contamination is detectable.
9.45 Filled APS units should be incubated in a clear container to ensure visual detection of microbial growth. … The selection of the incubation conditions and duration should be scientifically justified and validated to provide an appropriate level of sensitivity of detection of microbial contamination.
To summarize, the key takeaways of the Annex 1 draft are:
- process understanding
- risk evaluation assessment
- contamination control strategy
In other words, when the auditors come visiting, the key question you must be ready to answer is “Why?”.
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