In the pharmaceutical and allied industries outsourced facilities are often used to perform a wide range of activities. Both start-ups and established companies rely on the abilities of contractors. The relationship occurs at various stages of a product lifecycle from development, production, QC testing and distribution of pharmaceuticals, advanced therapy products, vaccines etc.

Outsourcing is a springboard for increased speed and efficiency and reliance on knowledge systems and resources which are missing in an organization.

There is some confusion regarding the responsibility and limits of authority of the MAH (marketing authorisation holder) / sponsor vs the entity performing the actual work when working with a CDMO / contract laboratory in outsourced operations.

• In 2021 the EMA issued a Reflection Paper on GMP and the responsibilities of the MAH. This in addition to:
  • Chapter 7 of the EU GMPs on Outsourced Operations
  • Annex 16 regarding the responsibilities of the QP at the MAH and the contractor
  • FDA Guidance on Quality Agreements

Despite all the requirements, there remain many unresolved questions regarding regulation, expectations and inspection handling.  This course will clarify through the use of real case studies, the hurdles found in inspections and audits with reference to the guidelines and regulations.