FDA EIR - Alliance Contract Pharma - February 18, 2014

An FDA abbreviated Good Manufacturing Practice (GMP) and Pre-Approval Inspection (PAI) of Alliance Contract Pharma, Llc, located in Harleysville, PA, was conducted from February 11 to February 18, 2014. The inspection was carried out in accordance with FDA compliance policies for Pre-approval and Drug Manufacturing Inspections, specifically CP 7346.832 and CP 7356.002. The primary focus was to assess the company's readiness to manufacture and its conformance to an application for NDA (b)(4) capsules, for which Alliance Contract Pharma performs banding and sealing of inactive bulk capsules. During the inspection, the FDA investigator reviewed various critical aspects of the firm's operations. These included training programs, Standard Operating Procedures (SOPs), batch production records, equipment qualification, process validation, cleaning validation reports, and the firm's quality and production systems. The review also encompassed investigations, corrective and preventive actions (CAPA), change controls, and incoming and release testing procedures. Notably, at the conclusion of the inspection, no Form FDA 483 Inspectional Observations were issued to management. This indicates that no deficiencies or violations were identified by the FDA during their comprehensive evaluation of Alliance Contract Pharma's facilities, processes, and documentation. Consequently, no specific regulatory actions were required from the company based on this inspection report.