Patheon API Manufacturing Inc – FDA EIR, Mar 30, 2018

A comprehensive Good Manufacturing Practice (GMP) inspection of Patheon API Manufacturing, Inc. in Greenville, SC, was conducted from March 22-30, 2018. This for-cause inspection, carried out under Compliance Program 7356.002F for active pharmaceutical ingredient (API) manufacturers, evaluated the firm's Quality, Facilities and Equipment, Laboratory Controls, Production, Materials, and Packaging and Labeling systems. While no significant deficiencies warranted a formal report, verbal observations identified areas for improvement. Key issues included the need for enhanced timeliness and tracking of quality incidents, such as deviations and Out-of-Specification (OOS) investigations, from initiation to completion, alongside improvements to the associated record-keeping system. Specific instances revealed delayed OOS investigations and failures to promptly initiate OOS forms. Concerns were also raised regarding the control of reference standards, with noted inconsistencies in log accuracy and completeness, and challenges in locating standards as described in records. Management acknowledged these observations and committed to addressing their quality assurance program. Required actions involve improving the existing quality system, aligning with Thermo Fisher Scientific's corporate quality standards, ensuring robust maintenance and review of reference standard control logs, and implementing a more cohesive system for documenting and completing quality-related incident investigations.