Quality system’s certification for health products

Evaluation audit

Which companies may be interested by assessment audit ?Laboratoire certipharm

 

Pharmaceutical companies including generics:

– To audit their suppliers of pharmaceutical active ingredients, pharmaceutical finished products, excipients, cosmetic products, medical device, service company, etc … whatever their geographical location in the world, according to GMP (and other) standards as well as the require the European Directives on health,

– To evaluate potential suppliers

Manufacturers of active pharmaceutical ingredients or pharmaceutical finished products who wish to evaluate their level of Good Manufacturing Practices (GMP)

 

certipharm-chimie-evaluation-2

 

Shared audits

Sharing audits consists of an audit on the same site for several contract givers

Shared audits bring quite a number of advantages both for contract givers and suppliers:

  • Cost reduction: the cost of the audit and the travel expenses are shared between the various contract givers.
  • Workload reduction for contract givers:

– The contract givers send their list of sites to be audited

– CERTIPHARM takes care of the arrangements right through to the sending of the report.

  • Tripartite confidentiality: a confidentiality agreement is signed between each contract giver, the site to be audited and CERTIPHARM.

– All contract givers sign a confidentiality agreement

– All auditors sign a confidentiality commitment

  • CERTIPHARM Confidentiality:
    CERTIPHARM observes the anonymity of all the contract givers for the same audit.

– CERTIPHARM communicates individually with each contract giver

  • A specific report to the contract giver:

– Once the audit is completed, each contract giver receives a specific report, the conclusions of which set out the auditor’s observations classified as critical, major or minor, and CERTIPHARM approves its conclusion.

– The report is the exclusive property of the contract giver.

  • Corrective action communication:

– CERTIPHARM sends the audit observations to the audited site requesting their corrective / preventive action plan (CAPAs) within 30 days

  • – The corrective action plan is reviewed and commented by the auditor and is forward to each customer for further action if applicable.