Inspection Readiness (IR) is a process of preparing for an inspection by a regulatory authority (such as FDA). Conducting an official review of documents, facilities, records, and any other resources related to the clinical trial is essential to any pharmaceutical company to ensuring employees' understanding and application of policies, standards, and procedures. Pharmaceutical organizations should allocate the right number of qualified resources to assure that inspection well prepared before, during, and after inspections. Clinical Operation Managers are traditionally driving the IR activities for the given clinical study with Quality Assurance (QA) support. Manufacturing/CMC Inspection Readiness is usually covered by separate QA GMP groups. In both cases, IR is a cross-functional effort.
Successfully completing an FDA inspection is all about managing risk by understanding your weaknesses, anticipating investigators perception and preparing your staff response. The human factor can be a pivotal factor during an inspection and may present the biggest risk without preparation. MEDVACON can assist in preparing your organization for the inspection by delivering rigorous and comprehensive FDA Inspection Readiness and FDA remediation services that are designed to provide cost efficient resolutions.
An FDA 483 or Warning Letter often only addresses a small portion of the true deficiencies in the quality system. MEDVACON can help determine the actual depth and breadth of the quality system deficiencies via a comprehensive FDA Compliance GAP Assessment. The GAP Assessment includes preforming baseline audits and developing a remediation plan to address all of the deficiencies to bring the Quality System or specific sub-section into compliance. For clients aware of deficiencies, MEDVACON's staff of compliance experts are at the ready to tackle those specific areas.
MEDVACON was employed to assist with the response to an FDA Warning letter received by an aseptic combination product client. MEDVACON assisted in conducting investigations into deviations and non-conformances in the aseptic manufacturing suites to produce the combination product. By deploying a team of experts to conduct investigations and assist this client in meeting stringent FDA commitment timelines MEDVACON resolved a highly technical issue with the combination product mechanical components and successfully identified and implemented complain processes that resolved the issue. The FDA commitment timelines were met, and the team continues to assist this client with ongoing investigations, closeouts, and quality systems consulting services.
MEDVACON assisted a pharmaceutical client to assess and remediate their Quality System in anticipation of an FDA Pre-Approval Inspection. MEDVACON deployed a team of experts at the client site to assess and identify the GAPs and gain client approval for MEDVACON to implement a holistic remediation of the entire quality system with a focus on automation of the quality system and ensuring compliance of that initiative from a CSV and 21 CFR Part 11.