Inspection Readiness
What is Inspection Readiness?
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 IR 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. 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.
Example Projects:
Pre-Approval Inspection (PAI) Readiness – Pharmaceuticals API
MEDVACON was engaged by a client that manufactures Active Pharmaceutical Ingredients (APIs) at two manufacturing Sites. The one site manufactures a UV filter used in cosmetics to achieve a SFP ratings. This GMP manufacturing is performed within the facility alongside cosmetic non-GMP manufacturing. The other site manufactures APIs and Excipients for human and veterinary uses. MEDVACON was engaged to perform GMP Inspection Readiness audits of both sites and to conduct the audits in a manner consistent with the FDA’s approach and methodology. A MEDVACON Sr. Auditor along with MEDVACON Chief Operating Officer conducted the audits and issued the reports. The client was extremely appreciative of the efforts and engaged MEDVACON to conduct 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.
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