Quality system’s certification for health products

Certification

Why should I get certified?

There is no requirement to be certified. In general, a production  site can be certified when there is no competent authority in the country where it is located to attest or certify that the site is working according to GMP rules.
To ensure my customers in the field of health products that arrangements are consistent on the one hand with their explicit requirements, on the other with minimum requirements defined by professionals.

How do I know if I am ready for certification?

An assessment or mock audit can reveal whether the arrangements in place are acceptable to consider an audit.
Should I or can I certify all or part of my quality organization?

It is better to certify everything related directly or indirectly to GMP.
If the transport sector health product is chosen for certification, all provisions relating to this activity must be within the  certification scope.

Why Certipharm ?

Certipharm has extensive experience in certification and auditors competences.
It is a competent body in the field, with auditors and members experienced certification.
What does Certipharm certification bring me?

Certipharm has a good reputation in the French pharmaceutical industry as well internationally.
Expertise, know-how and unmistakable recognition.
Provide various standards and guide third party guidance.

Certification obtained is then guaranteeing a well designed, implemented and maintained quality system. Audits from your customers can then be simplified and restricted to their specific needs, whilst duration and frequency of these audits can then be reduced.

 

pdf-downloadStandard CERTIPHARM N°219 version 1.2


CERTIPHARM certification is a single reference for all those working in the quality of health products. You receive numerous audits of customers, each with differing requirements.

 

pdf-download316-2 referentiel transport PS 032-7