Quality system’s certification for health products

Mutual audits

Mutual audits, a number of benefits for both contractors and suppliers:

  • Reduction of costs; the audit cost (and associated travel expenses) are shared between the different contractors,
  • Reduction of actions in the audit trail : audit documents are sent directly by each participant to CERTIPHARM which manages each step of the audit until completion,
  • Tripartite confidentiality: a confidentiality agreement is signed by each contractor by the main company being audited and by CERTIPHARM.
    • Signature of all principals of a privacy policy
    • Signature by auditors of a privacy policy
  • Confidentiality CERTIPHARM : the anonymity of all contract givers involved in a single audit is respected by CERTIPHARM.
    • CERTIPHARM communicates individually with the various contractors

Eg : through a pooling agreement with other contractors, using a code to represent :

      • Molecule audited
      • Site audited
      • Contract giver
  • Specific report for each contract giver :
    • the audit done, each contract giver receives a personalised report containing in conclusion the auditor’s findings, classified into critical, major or minor and endorsed beforehand by CERTIPHARM.
    • The report belongs exclusively to the contract giver.
  • Transmittal of corrective actions :
    • CERTIPHARM sends the audited site observations classified by auditor and request the corrective action plan within 30 days..

Standardized audit reports

CERTIPHARM experience with shared audits

Since 2007, signed an agreement with 10 French laboratories each year, share the cost of their audits of suppliers of active ingredients or finished products.

Different stages:

  1. Each contract giver sends its list of audits for the year to CERTIPHARM,
  2. CERTIPHARM establishes a table of sites, molecules and costs while preserving the anonymity of the contract giver,
  3. Each contract giver confirms its own list,
  4. CERTIPHARM starts programming the audits:
    • – making contact with the site
    • – fixes the date and selection of the auditor,
    • – signing confidentiality agreements
    • – audit
    • – sending the full report within 15 days to the contract giver with the invoice,
    • – sends the auditor’s comments (only) directly to the site with a request for corrective action plan (CAPA) within 30 days
    • – upon receipt of CAPAs, these are sent to contract givers with the auditor’s comments.
  5. Another type of poolied audits.

The sites to be audited regroup their customers by proposing that the audit is performed by CERTIPHARM to minimize the number of audits on site.

The same principles as above are then applied.