FDA EIR - Bachem AG - November 17, 2017

An FDA inspection of Bachem AG's human drug substance manufacturing facility in Bubendorf, Switzerland, was conducted from November 13 to November 17, 2017. This routine Good Manufacturing Practice (GMP) inspection focused on active pharmaceutical ingredient (API) manufacturing operations, guided by FDA's Active Pharmaceutical Ingredient Manufacturing Inspections program (CP 7356.002F) and ICH Q7A guidelines. The inspection aimed to ensure the firm's compliance with section 501(a)(2)(b) of the FD&C Act. The comprehensive, systems-based inspection covered Quality, Production, Materials, Facilities and Equipment, Laboratory, and Packaging and Labeling systems. A significant finding was that no FDA Form 483, "Inspectional Observations," was issued, indicating a satisfactory outcome. Management was cooperative, and no refusals were encountered. While no significant violations were identified, the report noted several items for follow-up during future inspections. These included monitoring the planned migration of the firm's training documentation system, reviewing a written justification for a recurring equipment defect related to an (b) (4) in FTM 009, and assessing the progress of planned improvements in supplier qualification. The supplier qualification enhancements involve establishing dual independent sources, direct procurement from (b) (4) manufacturers, increased auditing, implementation of Quality Agreements, and insourcing of (b) (4) manufacturing. Additionally, the next inspection should review the firm’s progress on a new process validation study for (b) (4) API. Overall, the inspection concluded favorably, with the firm demonstrating adherence to regulatory requirements.