FDA EIR - Alliance Contract Pharma - April 05, 2018

An FDA Pre-Approval Inspection was conducted at Alliance Contract Pharma, LLC in Harleysville, PA, from April 3-5, 2018. This inspection, carried out under regulatory framework CPGM 7346.832 for Pre-Approval Inspections, focused on evaluating the firm's readiness as a contract manufacturer of a bulk intermediate drug product for a New Drug Application (NDA). The inspection covered critical areas including Quality, Production, Facilities/Equipment, and Laboratory Systems. The firm's readiness for commercial manufacturing, conformance to the application, and data integrity were thoroughly verified. Review of process validation protocols, investigation procedures, change control, and CAPA systems revealed no significant deficiencies. Equipment qualifications, cleaning validation, and warehouse temperature mapping were also assessed and found to be satisfactory. Laboratory systems, including analytical method transfers and electronic data integrity, demonstrated compliance. Crucially, the inspection concluded without any Form FDA-483 Inspectional Observations being issued to management, indicating no main violations or issues. The FDA investigator informed management that a recommendation for 'approval' would be submitted for Alliance Contract Pharma, LLC's role in the referenced NDA, with the final decision resting with CDER. No samples were collected, and no refusals were encountered during the inspection, meaning no immediate required actions were identified at the time.