GMP Audit Services
Reliable Audit Solutions to Ensure Global Compliance and Safeguard Your Supply Chain
Reliable Audit Solutions to Ensure Global Compliance and Safeguard Your Supply Chain
We are reputable provider of 17 years of experience in GMP audits to ensure products meet industry standards and quality standards. Our experienced team conducts GMP audits globally, assessing a pharma company’s control over processes, facilities, and QMS, including API, intermediates, raw materials, warehouses, and packaging facilities. Trust Zenovel for reliable GMP audits that help maintain excellence in pharmaceutical manufacturing.
We conducts third-party GMP audits using experienced auditors to assess a supplier’s compliance with regulatory standards, including detailed documentation review, on-site inspections, staff interviews, and comprehensive reporting to ensure adherence to Good Manufacturing Practice guidelines.
We understand the demands and constraints placed on pharmaceutical firms, as well as the pressure their suppliers face from audits. This inspired us to develop a strategy that benefits all stakeholders while offering a premium audit service.
Our framework provides elite audit services tailored to the demands of pharmaceutical firms’ effectively addressing challenges in supplier auditing. We prioritize adherence to standards, regulations, and impartiality, avoiding conflicts of interest and supplier-customer interactions.
We streamline auditing process by identifying top-tier auditing firms and auditors, coordinating all stakeholders to align audit schedule with auditor and sponsor timelines.
Upon contract agreement, we promptly initiate audit planning, scheduling audit days based on the auditor and sponsors deadlines. After scheduling, the company seeks competent auditors and qualified teams to effectively handle and execute the audit.
Utilize our complete audit life cycle management services to streamline your supplier audit, covering planning, execution, reporting, and CAPA follow up, allowing you to efficiently manage and conclude audits for your suppliers. From here we take care of audit from beginning to the end.
We conducts third-party GMP audits using experienced auditors to assess a supplier’s compliance with regulatory standards, including detailed documentation review, on-site inspections, staff interviews, and comprehensive reporting to ensure adherence to Good Manufacturing Practice guidelines.
We provide Joint Audit Services, a collaborative auditing method where multiple parties collaborate. This approach ensures comprehensive assessments, optimizes efficiency, reduces duplication, and enhances transparency. It leads to improved compliance and quality. Trust Zenovel for expertly managed joint audit services, fostering cooperation and driving excellence in regulatory compliance.
We are qualified to audit a wide range of international manufacturers of pharmaceutical drugs and to all applicable regional and global compliance requirements.
Auditors maintain a high level of impartiality in their evaluations, assessing sponsors’ specific requirements and communicating them to the auditors using unbiased standards
The audit sponsors, auditors, and sponsors are all subjected to strict confidentiality conditions, including through NDAs or CDAs, to ensure the integrity of all information.
The EMA guidelines mandate that auditors and sponsors must have no commercial connections, which auditors thoroughly examine during the audit process to ensure regulatory compliance.
Each sponsor receives a detailed report tailored to their interests and specific updates based on their criteria.
We offer global audit services with native auditors, ensuring comprehensive coverage and adherence to international standards in any country.
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