+33(0)2 97 13 47 76 contact@certipharm.com
COFRAC
More than 20 years
of certification

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Assessment audit or audit second party

What it is:

The assessment audit enables you to assess the quality of your suppliers and/or partners, detect associated risks and involve them in a shared approach to continuous improvement.

These audits are carried out in accordance with the applicable regulatory standards:
Eudralex, USP, ICHQ7, Veterinary products, IPEC PQG, ISO 9001, ISO 22 716, Medical devices...

 

The service aims to:

-> Measure the application of the standards,
-> Evaluate the organization of the quality system and quality risk management,
-> Measure the effectiveness of the rules implemented to comply with the relevant standards.

 

 

For whom/why?

Evaluation audits are intended for:

-> Pharmaceutical companies :
- To audit their suppliers of finished products, active pharmaceutical ingredients, excipients, cos- metics, packaging material, medical devices, etc., worldwide;
- To evaluate potential suppliers

-> -> Manufacturers of active pharmaceutical ingredients or finished products who wish to assess the level of their quality system in relation to the relevant standard.

 

MUTUALIZING AUDITS

Mutualizing audits offers a number of advantages for both customers and suppliers:

- Reduced costs and travel expenses
- Optimization for audited sites, with a reduction in the number of audit days
- Respect for the anonymity of each customer

 

BUSINESS ORGANIZATION

- Receive audit requests from each customer
- If customer agrees to mutualize their audits, sharing of planned audit list
- How the service is provided (see diagram below)
- Specific audit report for each client
  

 

The audit report belongs to the customer.

 Assessment Audit Cost :

Contact us to receive a quote :

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