Controls are essential
After all, our tests are the basis of vital medical decisions
Once production is complete, the Quality Control team checks the finished packages in a batch at random. This includes checks such as a functional test using analysers to ensure that the reagent delivers reliable results. The batch can only be released once the test has been passed.
The in-process control is used to analyse the contents of the prepared reagents. If the required specifications are not met, adjustments must be made until they are. Depending on the product, an in-process control can take anything from 30 minutes to several days. Once the production stage is complete, the finished package is subjected to a further quality control.
Trust is good - controls are better
Diagnostics production at Roche is strictly monitored. Even the production process itself involves several control steps, which check things like the amount of reagents used. Once products have been fully packaged, final inspections are conducted at random. Only after this can the newly produced batch be released for sale.
Roche continuously monitors the quality of its products and processes. Independent institutions like TÜV or DEKRA also act as additional control bodies. They conduct routine audits to check the quality of the industrial production plants.
The importance of the CE mark
The CE mark on in vitro diagnostics indicates compliance with certain European quality standards during the manufacturing of the product. This is based on an EU Directive, which summarises the regulations that medical product manufacturers have to observe in order to display the CE mark on their products for the European market. The aim is to protect the health and safety of patients and users.
Spontaneous control visits
The health authorities keep a very close eye on the production of potentially vital drugs and diagnostic products. And not all audits are pre-announced. This is the result of EU legislative decisions, which allow spontaneous monitoring in order to ensure that legal regulations on quality assurance are observed during everyday routine operations.
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Photographer: Philipp Wente