In any compliant quality system the initial qualification of a vendor represents only the initial step in the relationship. Once initial audits are completed, Quality Agreements and Commercial contracts signed and your vendor moves into routine operation the countdown to their requalification should begin.

Requalification audits represent an important element of the Quality System and afford the opportunity to get “boots on the ground” at the vendor site.

The process of vendor requalification can take many forms with not all requiring an on site audit. Sites may also be requalified using audit questionnaires, virtual audits or desktop audits, however, the chosen approach should be appropriately assessed and justified.

Predetermined re-audit periods of 3 years are commonly seen and whilst this ensures a level of consistency across all vendors it doesn’t take into account the relative risk presented by a vendor, nor does it factor in the outcomes from regulatory inspections or findings from your own audits. For example there is a greater risk presented by a CMO manufacturing a sterile biologic that has recently had a critical finding during a regulatory inspection than a Site of Importation.

For this reason a risk based approach to vendor requalification is recommended using all available information to drive the program including performance metrics. In doing so a holistic picture of the vendor is available which can drive a more targeted approach during the requalification audit. For example if performance metrics indicate a high number of overdue deviations focus can be given to this area of the Quality System.

MIAS Pharma has a wealth of experience in auditing across all dosage forms and facility types with a global network of auditors that can assist in managing your requalification program.

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