Which companies may be interested by assessment audit ?
• 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)
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.