Environmental monitoring, learn to improve!
The microbiological quality control in the pharmaceutical industry is not only based on the final analysis of a representative sample of the product, but must also take into account the environmental quality control of the facility and the elements used during its manufacture.
Where are the pharmaceutical regulations evolving to?
The microbiological contamination control in the pharmaceutical environment has always been present in the regulatory documents. GMP’s Annex 1, applicable in the manufacture of sterile products, states the quality that can have the different manufacture rooms/zones (microbiological amount and not viable particle). Additionally, the USP, in the microbiological environmental control chapter <1116>, describes the different forms of control and proposes control frequency guidelines for each type of room.
The evolution of the pharmaceutical’s regulation, because of the publication of the ICH’s Q9 (Quality Risk Management) and Q10 (Pharmaceutical Quality System), has meant a great change in the way to take advantage of the data generated during the environmental monitoring of facilities. Likewise, the importance of continuous improvement and the detection of changes in the behavior trends of the processes has implied the need to perform a statistical treatment of the generated data.
How has the data been managed historically?
In the past, the execution of environmental monitoring controls was a manual task, which was usually documented through sampling templates and log books of incubation and result reading. In addition, the generated data was transferred to Excel sheets or complex statistics systems for the execution of reports.
However, the review of the Data Integrity directives has generated uncertainty about the compliance of data integrity during its transference/manipulation. In the latest FDA audits the number of deviations related to these ‘Compliance’ issues are increasing.
What about SherpaPharma?
SherpaPharma is an informatic solution provided by Tiselab that allows:
The global management of the environmental monitoring process ensuring compliance with the monitoring plan of the samples.
The univocal identification, through barcodes, of samples and sampling metadata (who, when and where it was taken).
A complete tracking of the process of sample incubation to avoid the loss of traceability of the process.
An identification of the person who enters the results.
The execution of specific reports that allow evaluating the fulfillment of the regulatory requirements in the control of facilities or personnel dress procedure, through customized filters.
In order to correctly carry out the process of environmental monitoring, it is necessary to evaluate each one of its steps.
Much more to come!
From the SherpaPharma team, we want to detail each of the steps of the environmental monitoring process, based on a series of periodical publications within the blog of our website. In this way, we aim to establish which are the most generalized practices in the pharmaceutical companies for each step of the environmental monitoring of facilities and/or services.