Do you need support in cleaning validation? We can support you in defining the best practice approach in setting up plans and protocols for cleaning validation.
We can also validate your analytical method and analyze swab samples for active pharmaceutical ingredient (API) residues or check for the absence of cleaning agents.
Don’t hesitate to contact us for more information about our cleaning validation services.
What is Cleaning Validation?
In the pharmaceutical sector, cleaning validation is mandatory to ensure that a cleaning process removes chemical and microbial residues from the active, inactive, or detergent components of the product manufactured in a piece of equipment.
Analytical methods used to determine the absence of API must be properly validated to demonstrate their ability to detect any remaining API. This approach applies to all manufacturers operating in the pharmaceutical GMP environment.
Why QbD Group?
The pharmaceutical industry focuses on cleaning validation because cross-contamination of previous batches must be avoided under all circumstances to ensure patient safety.
Cleaning validation for the introduction of new products into a manufacturing facility requires significant resources from the QC department for analytical method validation and sample analysis.
In many cases, this work is on top of the routine QC and R&D activities performed by the laboratory.
Outsourcing validation and the necessary QC work not only helps to allocate your QC staff to their core activities but also provides a clear picture of the associated costs and timelines in advance of the project.
Quercus Labs – part of the QbD Group – has a GMP license, an ISO 17025 certificate and is audited by the Belgian FAGG. We are qualified and happy to help you.
Outsource your testing
You can outsource a specific test, the analytical method validation, as well as the complete follow-up of your cleaning validation program to Quercus, including set-up and reporting.
Once we receive a request for analysis, you will receive a detailed quote and a lead time for reporting the analysis results.
Don’t hesitate to contact us so we can listen to your needs and provide you with the right service.