FDA EIR - PharmaZell GmbH - September 22, 2017

An FDA surveillance inspection of PharmaZell GmbH, a manufacturer of active pharmaceutical ingredients (API) for human drugs, was conducted from September 18 to September 22, 2017. This routine good manufacturing practice (GMP) inspection was performed under Compliance Program Guidance Manual (CPGM) 7356.002F and guided by International Conference on Harmonization (ICH) Q7A for APIs.The inspection identified three key issues documented in an FDA Form 483. Firstly, previous corrective actions were inadequate, failing to prevent the re-occurrence of manufacturing deviations. Secondly, precision and limit of quantitation (LOQ) were not adequately performed during method validation for three test methods essential for releasing related substances and residual solvents. Additionally, the analytical test method validation SOP permitted omitting precision testing during cleaning validation studies. Thirdly, the stability program was found deficient, as it did not include an adequate number of API grades in its annual assessment.PharmaZell GmbH's management acknowledged these observations and committed to providing a written response to the Agency within 15 business days. The inspection was recommended for a Voluntary Action Indicated (VAI) classification.