Quality assurance

The Alphalyse philosophy is quality in everything we do

We have manufacturing authorization from the Danish health authorities, enabling us to perform host cell protein (HCP) analysis of biologics and pharmaceuticals according to EU and US GMP (EMA/FDA).

According to the GMP regulations, you must validate the HCP assay for the individual product. Alphalyse validates according to ICH guidelines or specific customer wishes.

Our quality management system is based on GMP and ensures that we meet customer needs. We use SOPs for all critical steps in all analysis processes, from personnel training to supplier selection. Our personnel documents all work packages thoroughly, ensuring traceability. Furthermore, customers audit our regulatory design regularly, and we implement appropriate changes based on customer-specific needs.

CDAs

You do not have to sign a confidentiality agreement (CDA) with us for our services, but if needed, we offer two ways of working together:

  1. Signing or modifying our standard CDA
  2. Using your own CDA

We have developed a standard CDA since many organizations utilize CDAs for collaborations. Our standard CDA considers your interests as a customer and our interests as a supplier. Our overall aim is to help your project progress, and your samples and the generated data from our analysis are your property.

Please get in touch with us for more information about a CDA if this is preferable for your organization.


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