By Cathy L. Burgess, Donald E. Segal and Guillermo Cuevas, Alston & Bird LLP
Last month, FDA released a draft guidance document entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements.” The guidance addresses relationships between the entities that introduce a drug into interstate commerce (the “Owner”) and third parties that perform some or all of the manufacturing operations for the product (the “Contracted Facilities”). The guidance describes how Owners and Contracted Facilities can use Quality Agreements to define responsibilities associated with manufacturing activities in a manner that is consistent with regulatory requirements.
The draft guidance expands on existing guidance contained in ICH Q7, Q9 and Q10 that collectively recommend supplier quality agreements, effective oversight and monitoring of outsourced operations. Briefly, ICH Q7 advises drug manufacturers to establish formal agreements with their contractors on current good manufacturing practice (CGMP) responsibilities. ICH Q9 provides guidance regarding supplier quality management, including supplier qualification, audits and implementation of quality agreements. ICH Q10 clarifies that the “pharmaceutical company,” described in the new draft guidance as the Owner, bears ultimate responsibility for outsourced activities and for the quality of the product.