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Library > White / Technical Paper

Cleaning Validation - What do you need to consider to ensure a successful outcome?

Format: PDF file | Document type: White / Technical Paper
Related applications: Contract services (outsourcing) , QA/QC
RSSL610

The data used to determine the success of a cleaning validation is built upon both the effective evaluation of the manufacturing plant and the robustness of the validated analytical method. In order to ensure the safety of the consumer, there must be a high degree of confidence in the analytical results in order verify the absence of residues at the prescribed limits on the various equipment surfaces. This white paper discusses the over-arching strategy for performing a successful cleaning validation, with detail on some of the key factors to consider at both the manufacturing and analytical stages, highlighting many common pitfalls to avoid.

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Cleaning Validation - What do you need to consider to ensure a successful outcome?

Cross contamination must be avoided in the pharmaceutical industry at all costs. Successful cleaning validation ensures that patients are not put at risk due to cross contamination. The process can be divided into a number of sections each of which must be fully understood. Areas of concern must be addressed to ensure a successful outcome across the entire process.