FDA EIR - Pharmaceutical Manufacturing Research Services, Inc (PMRS) - May 25, 2017

Pharmaceutical Manufacturing Research Services, Inc (PMRS) underwent a pre-approval cGMP inspection by the FDA from May 22 to May 25, 2017. The inspection, conducted under FDA's drug manufacturing and pre-approval guidelines, focused on the company's capabilities for a new drug application product. The primary violation documented on Form FDA 483 cited deficiencies in calibration procedures for instruments, apparatus, gauges, and recording devices, specifically referencing 21 CFR 211.160(b)(4). Key issues included the interchangeability of components for dissolution testing units (e.g., vessels, paddles) between different systems without re-calibration. Additionally, pH meter calibration procedures were found deficient: pH probe thermometers were uncalibrated, buffer temperatures during standardization were not monitored or recorded, and the firm did not adhere to USP <791> requirements for pH meter standardization. Beyond the formal observation, the inspection highlighted several discussion points requiring attention. These included improving labeling and tracking of laboratory consumables like desiccants and HPLC trays, refining analytical methods to monitor solvent fronts and specify burette volumes, and enhancing investigation protocols for out-of-trend results, particularly when multiple samples or system issues are involved. The FDA also recommended investigating unexplained peaks in stability testing and ensuring that trainers possess adequate experience. PMRS verbally committed to submitting a formal response to the FDA's District Director within 15 business days to address the identified concerns and implement corrective actions.