FDA Inspection Readiness
MEDVACON can assist in preparing your organization for an inspection by delivering holistic Inspection Readiness services that are designed to achieve the best possible outcomes.
What is Inspection Readiness?
FDA 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 scope of the inspection is essential to being prepared. Equally important is understanding the logistics required for hosting and managing an inspection. Having well thought out procedures and conducting practice inspections has been shown to significantly improve the outcomes of actual regulatory inspections.
Firms should dedicate time and resources to ensure that all aspects of investigation management are resourced appropriately, including before, during and after the agency visit. Clinical Operation Managers traditionally drive inspection readiness activities for a 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.
Following diligent preparation, successfully completing a regulatory inspection becomes all about managing risk by understanding your weaknesses, anticipating investigator questions and perceptions, and preparing your staff to respond accordingly with the support of objective evidence. The human factor often determines success or failure during an inspection, and may present the biggest risk if preparation is inadequate.
Example Projects
Pre-Approval Inspection (PAI) Readiness – Pharmaceuticals API
MEDVACON collaborated with a client involved in manufacturing Active Pharmaceutical Ingredients (APIs) at two distinct facilities. The first site produces a UV filter used in cosmetics, essential for achieving specified SPF ratings. This production occurs under Good Manufacturing Practice (GMP) regulations, coexisting with non-GMP cosmetic manufacturing. The second site focuses on producing APIs and excipients for both human and veterinary applications.
MEDVACON was tasked with conducting GMP Inspection Readiness audits at both locations, aligning their procedures with the FDA’s standards and methods. The audits were led by MEDVACON’s Senior Auditor and the Chief Operating Officer, resulting in comprehensive reports. The client valued the expertise provided and subsequently retained MEDVACON for additional consulting services.
Pre-Approval Inspection (PAI) Readiness – Pharmaceuticals
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.