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Quality & Certificates at Le Mans (Séripharm)

Our Quality Assurance team is strongly committed to meet Agencies Requirements and frequently perform internal and external audits.
Terms such as SOP, validation, calibration, reference standards, stability, methods transfer…are part of our daily vocabulary.

Our versatile cGMP kilolabs, labs and industrial suites are designed for handling HPAI at or below 1µg OEL.

Our industrial manufacturing HPAI suites are fully independent and are able to synthesize and purify up to several hundreds Kg of highly potent API under class 10 000 confinement.

At the laboratory scale, material can be synthesized under cGMP or non-cGMP conditions, depending on the needs. On industrial scale, cGMP conditions are applied.

Regulatory Compliance

The site has been successfully inspected several times by the US FDA since 1994.
Furthermore the site is ISO 14001 certified.

Download ISO 14001 certificates

Séripharm Quality / Certificates

Groupe Novasep >

Quality & Certificates at Le Mans (Séripharm)

Regulatory Compliance