SherpaPharma process

Microbiological monitoring: elements to consider

The microbiological quality control strategy of a pharmaceutical manufacturing facility relies on different factors:

  • The regulatory environment:

    What regulations do apply to our case? It is relevant to consider which criteria could be used to evaluate our company during an audit. Are all the kinds of pharmacopoeia equivalent (USP, EP, JP)? In some cases, there are significant differences between the mandatory rules to comply depending on the regulatory authorities. In this regard, adopting requirements that comply with the different regulatory authorities, instead of focusing in a particular regulatory environment, could be an interesting strategy, thus making our company less susceptible to the violation of the rules in any regulatory workframe.


  • The facilities:

    Where do we want to apply the environmental monitoring process? Is it a new facility or an already functional working space? The historical state of the facilities affects not only the definition of the sampling points but our criteria to set the alert and action levels for these points. So, taking into account which would be the future workplace to monitor could hugely assist us in the planning of the whole process.


  • Contamination risk: workplace.

    What are we using our cleanrooms for and which is the personnel and material flow in them? Which is the microbiological quality expected from the product or process realized in there? The control strategy must be defined by considering the risk of the end user, for which it is of vital importance to analyze the risk of a product contamination during the manufacturing process, and thus trying to minimize it to the lowest possible levels from the very start (quality by design).


  • Contamination risk: personnel.

    Another relevant aspect to consider is how close is the working staff to the end product. Considering that people are usually the biggest contamination source, the training of the working personnel and the usage and proper state of the required garments are key points in order to reduce the contamination risk.

In the following articles we will develop the microbiological control factors in a facility further:

  • European regulatory environment. GMP Annex 1. Differences between 2008 and 2018 versions.
  • North American regulatory environment: Guidance for industry and USP.
  • Sampling points design in a new facility.
  • Sampling points design in an already functional working space.
  • Other aspects to consider about manufacturing facilities.
  • Cleaning & disinfection patterns.
  • Contamination control in personnel.


Do you think we are missing any relevant aspect?


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