Certipharm

Certipharm: Support for certification and assessment of GMP compliance of industrial sites in accordance with current standards, and audit of management systems

Certification of the transport of healthcare products, Assessment audits

CERTIPHARM, Non-profit organization, created in 1990 following the National Pharmaceutical Industry Quality Workshop,initially to respond to a need for approval of suppliers, service providers, and sub- contractors, to the pharmaceutical industry and associated industries..

Over the years, two activities have been developed:
Certification of the transport of healthcare products and ' Assessment audits.

President signature :

$cofrac-certifie-CERTIPHARM$

Accréditation COFRAC n° 4-0617
Details on www.cofrac.fr

Our Services

Certification for the transport of healthcare products

A standard for the transport of health products has been written in collaboration with representatives of transporters, the pharmaceutical industry and specialist auditors, in order to define the good rules for the transport of health products.
CERTIPHARM has been accredited by Cofrac since 2020, for its certification under the CERTIPHARM standard for the transport of healthcare products n°032.

Assessment audits

CERTIPHARM carries out assessment audits for the pharmaceutical industry to help them assess their suppliers and subcontractors (Active Pharmaceutical Ingredients; Finished Products; Primary and Secondary Packaging; Excipients; ...) worldwide.

GMP certificate of compliance

For activities involving the storage, distribution, etc. of health products, CERTIPHARM carries out a complete audit of your quality system in order to assess its compliance with Good Distribution Practices (GDP).

Certification

CERTIPHARM certification is a benchmark for all those working in the field of health product quality.

What it is: CERTIPHARM certification is aimed at all logisticians, transporters and freight forwarders in the field of health products.

For whom:  CERTIPHARM certification is aimed at all logisticians, transporters and freight forwarders in the field of health products.

Why: certification is a powerful way for your organisation to demonstrate the quality of your expertise. It proves that your organisation has established a culture of risk management and meets the specific requirements of transporting healthcare products.

Our CERTIPHARM certification under the CERTIPHARM Transport of Healthcare Products standard no. 032 has been recognised by Cofrac since 2020, through our Cofrac accreditation no. 4-0617 (scope available at www.cofrac.fr ))
CERTIPHARM is the only company to offer this specific certification for the transport of healthcare products.

Accreditation:

In France, Cofrac is the only reference body for accreditation.

The French Accreditation Committee (Cofrac) was set up in 1994 on the initiative of the public authorities. Historically, it has been entrusted with a public service mission: ensuring the competence and impartiality of conformity assessment bodies (inspection bodies). It is now involved in the accreditation of certification bodies, particularly for quality management systems.

In 2020, Certipharm obtained Cofrac accreditation no. 4-0617 (scope available on www.cofrac.fr) for its certification under the Certipharm 032 Transport of health products standard. www.cofrac.fr )-

This is recognition of Certipharm for the robustness of its quality system, its skills management and its impartiality in handling certification applications.

BPD Certificate of compliance:

For your storage, logistics and distribution activities (which are not covered by certification under the Certipharm 032 Transport of healthcare products standard), CERTIPHARM offers to check the compliance of your quality system with GMP (Good Distribution Practices) during the audit. Depending on the deviations observed, CERTIPHARM can issue you with a certificate of compliance with GMP.

What it is: Good wholesale distribution practices are a reminder of the fundamental principles that must be respected in the wholesale distribution of pharmaceutical products (quality management, personnel, premises, equipment, etc.).

For whom:  The BPDG concern the wholesale distribution of medicinal products for human use carried out by pharmaceutical establishments: they are applicable to manufacturers, operators in charge of wholesale distribution operations, stockists and wholesale distributors, importers, and any pharmaceutical establishment engaged in the wholesale distribution of medicinal products on national territory or from national territory

Why: The responsible pharmacist is required to ensure that storage, distribution and transport conditions guarantee the proper conservation, integrity and safety of medicinal products for persons authorised or entitled to supply medicinal products to the public or to use them. The certificate of compliance can be sent to the pharmacist in charge

Assessment audits:

C’est quoi : What it is:

These audits are carried out in accordance with the applicable regulatory standards:
These audits are carried out in accordance with the applicable regulatory standards: Eudralex, USP, ICHQ7, Veterinary products, IPEC PQG, ISO 9001, ISO 22716, medical devices, etc.

The audit reports belong to the client and not to CERTIPHARM.

For whom/why:  
Assessment audits are aimed at:
- Pharmaceutical companies:
- to audit their suppliers of finished products, active pharmaceutical ingredients, excipients, cosmetic products, packaging items, medical devices, etc., regardless of their geographical location in the world;
- 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 Good Manufacturing Practices (GMP).

Sites certifiés en 2023

+0 ans

years of certification for the transport of healthcare products

Sites audited for assessment audits in 2022

of satisfaction [see the results of our quality survey*].

Examples of certified sites

*Results of our quality survey

CERTIPHARM, following a quality survey carried out throughout 2022 among all its certified personnel (79% return rate), has obtained a very satisfactory satisfaction rate with the following results (for surveys concerning certification):

For the quality of CERTIPHARM's overall service :
Excellent : 26,67 %
Very satisfactory: 60,00 %
Satisfactory 13,33 %

For the For the quality of CERTIPHARM's overall service :
Excellent : 33,33 %
Very satisfactory: 26,67 %
Satisfactory 33,33 %
No response to this question 6,67 %

The credibility of the CERTIPHARM certificate :
 Excellent : 33,33 %
Very satisfactory: 33,33 %
Satisfactory 26,67 %
No response to this question 6,67%

Following a quality survey carried out in October 2022 among our principals for the "evaluation audits" section (41% return rate), CERTIPHARM obtained a 100% satisfaction rate.

Certipharm: Support for certification and assessment of GMP compliance of industrial sites in accordance with current standards, and audit of management systems

President signature :

Our Services

Certification for the transport of healthcare products

Assessment audits

GMP certificate of compliance

Certification

Accreditation:

BPD Certificate of compliance:

Assessment audits:

Examples of certified sites

*Results of our quality survey

Liens rapides

Lastest News

Version 8.1 du référentiel 032 Transports de produits de santé

Nouveau certifié : DERET TRANSPORTEUR !

Recherchons – Auditeurs H/F

Attestation de Conformité aux Bonnes Pratiques de Distribution (BPD)