API Manufacuring

While serving in FDA’s Foreign Inspection Cadre from 1986 until 2004, Robert conducted many sterile and non-sterile international API (active pharmaceutical ingredient) inspections where the API was either produced by chemical synthesis or cell culture/fermentation processes. Robert has a sound knowledgeable of ICH Q7 guidance and FDA’s requirements for API process manufacturing.  During his time at FDA, Robert documented significant findings at many foreign API facilities resulting in Warning Letters and Import Alerts. 

While working as a consultant, Robert conducted several API audits, one foreign site received an FD-483 for significant GMP issues and laboratory data integrity issues. Robert was to conduct an audit to determine effectiveness of the corrective action plan submitted to FDA.  Prior to performing the audit, Robert’s CV was first subjected to CDER’s review and approval.  Roberts audit verified and documented that the data integrity remediation efforts and assessed the recently instituted systems, that if followed, should prevent similar data integrity issues from occurring. Robert’s audit also identified considerable improvement in their compliance strategy and concluded that the data integrity issues were adequately addressed.  Another CDER requirement with this assignment was that Robert had to submit his written audit report simultaneously to the client and CDER. Robert was then interviewed by the assigned CDER Compliance Officer regarding the facility audit and was requested to provide his verbal assessments of the client’s approach to handling the data integrity and compliance issues. CDER accepted his response and a subsequent FDA inspection a few months later revealed only minor GMP issues, resulting in the removal of the Import Alert. 

Robert remains current with ICH Q7 and applicable FDA guidelines relating to the manufacture of APIs.