In case of the audits to active substances manufacturers, the audit to the manufacturer shall be renewed at least every three years. In case of audits to other type of manufacturers (non active substances), the following criteria is applied once the audit is performed:

5 years
Audits without critical observations and/or opened major observations and when having a Quality Agreement signed by the manufacturer with each one of the interested associates, which guarantees the control of significant changes. In case of packaging materials manufacturers, a validity of 5 years will be applied as long as no critical observations are identified.

3 years
Audits without opened critical observations and when having a Quality Agreement signed by the manufacturer with each one of the interested associates, which guarantees the control of significant changes.

Less than 3 years
For those audits with opened critical observations or provided that there is not enough confidence that the changes will be notified, a period of less than three years will be established in order to review the committed action plan.

The expiry date derived from the application of this overall criteria will be established for each case when the audit report is reviewed and a chapter justifying the assigned expiry date will be included.

Each one of the associates/clients shall establish the final expiry date based on its overall supplier validation process.