Providers' Approval – a Burden or Real Necessity? Why and What do i Have to Assess?

Orna Dreazen, Nextar Chempharma Solutions, Ness Ziona, Israel

Development of pharmaceutical product is a complex and expensive process.

The products are developed for human use and must be of proper quality to ensure patients' safety.

The industry relies heavily on raw materials and services providers. Their products directly affect the quality of the final drug product.

The quality of the Active Pharmaceutical Ingredient (API), the excipients, as well as the primary packaging is pivotal to the final product: i.e. interaction between the materials and the primary package may result with leachables and extractables which may be toxic and affect the patients.

Pharmaceuticals companies are not only obliged to assess the quality of the products prior to their usage but also to assess their producers and providers to ensure consistent quality of products.

The lecture will concentrate on lessons learned from providers' approval activities.

We shall discuss work prioritization based on risk assessment as well as critical issues to be audited during the approval process.