Pharmaceutical Establishment:
in accordance with Good Manufacturing Practices.

Quality certifications

In 2018, ARaymondlife chose to streamline its certifications to focus on a single quality certification:

> The standard NF EN ISO 13485: 2016

 

It specifies the requirements of the quality management systems (QMS) that ARaymondlife applies to the manufacture of medical devices. In February 2018, LNE GMED recommended the continuation of this certification and its extension to the 2016 version.

• multiservice quality division: management of product and process validation and qualification plans; operational quality assurance; laboratory analyses.

• fully automated in-process quality control.

Quality and regulatory affairs

ARaymondlife follows a process of continuous quality improvement. Since 2008, ARaymondlife has been recognized as a pharmaceutical establishment operating under the authorization of the French National Agency for food safety, nutrition, environment, and labour (ANSES). 

European GMP

ARaymondlife meets the regulatory requirements of European Good Manufacturing Practice (GMP):
• batch release under supervision of 2 pharmacists,
• product and development quality assurance,
• drug master file approved by US FDA and Canadian government,
• Japanese registration as medical device manufacturer.

Products focus
NEWS
RayDyLyo ARaymondlife
02/22/17

ARaymondlife presents RayDyLyo for use with nested vials  [+]

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