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What are the most effective strategies for conducting timely and efficient GMP audits?

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GMP audits are essential for ensuring compliance, quality, and safety in the pharmaceutical, biotechnology, and medical device industries. However, conducting them can be challenging, especially in a dynamic and complex environment. How can you plan, execute, and follow up on GMP audits effectively and efficiently? Here are some strategies that can help you achieve your audit objectives and improve your quality management system.

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Eze Samson Chibueze, MS, MLS(ASCPi), AMAPH

Medical Laboratory scientist || CORU Reg. || IVD Field Application Specialist || Lead Auditor (ISO 9001:2015) ||…
Enrique Garcia

IATF16949, ISO9001, ISO45001, ISO14001, ISO27001, TISAX.

1 Define the scope and objectives

Before you start an audit, you need to have a clear and specific purpose and scope. What are the regulatory requirements, standards, and guidelines that apply to the auditee? What are the critical processes, systems, and risks that need to be assessed? What are the expected outcomes and deliverables of the audit? By defining these elements, you can focus your audit on the most relevant and important areas, avoid unnecessary or redundant work, and communicate your expectations to the auditee and the audit team.

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Anthony Assumang

PhD Student || Drug Delivery System
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The auditee should be involved in all aspects in defining the scope. This will keep both parties in agreement. Both parties should conform to the standards of their regulatory body in their jurisdiction.

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Enrique Garcia

IATF16949, ISO9001, ISO45001, ISO14001, ISO27001, TISAX.
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Alcances de una Auditoría GMP: - Cumplimiento Regulatorio. - Calidad del Producto. - Instalaciones y Equipamiento. - Documentación. - Validación de Procesos. Objetivos de una Auditoría GMP: - Identificación de No Conformidades. - Mejora Continua. - Asegurar la Conformidad. - Evaluación de Riesgos. - Garantizar Trazabilidad. - Capacitación del Personal. Estos objetivos buscan mantener altos estándares de calidad, seguridad y conformidad con regulaciones GMP en la fabricación de productos.

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2 Prepare a checklist and a plan

A checklist is a useful tool for ensuring that you cover all the aspects of the audit scope and objectives. It can also help you organize your audit activities, allocate your resources, and track your progress. A checklist should include the audit criteria, the audit evidence, the audit questions, and the audit findings. You can use a standard checklist or customize it according to the specific needs of each audit. A plan is a document that outlines the audit schedule, the audit team, the audit methods, and the audit logistics. It can help you coordinate your audit activities, manage your time, and communicate your arrangements to the auditee and the audit team.

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Enrique Garcia

IATF16949, ISO9001, ISO45001, ISO14001, ISO27001, TISAX.
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Preparar una lista de verificación para una auditoría GMP (Buenas Prácticas de Manufactura) implica identificar y detallar los elementos clave que deben ser evaluados durante la auditoría. 1. Cumplimiento Regulatorio: 2. Instalaciones y Equipamiento: 3. Documentación 4. Control de Materias Primas 5. Validación de Procesos: 6. Control de Cambios 7. Seguridad del Producto 8. Capacitación del Personal 9. Monitoreo y Control de Calidad 10. Registro y Documentación de Incidentes

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3 Conduct the audit professionally and objectively

During the audit, you should follow the audit plan and the checklist, but also be flexible and adaptable to any changes or issues that may arise. You should conduct the audit professionally and objectively, respecting the auditee's culture, policies, and procedures. You should collect sufficient and reliable audit evidence, using various sources and methods, such as interviews, observations, documents, records, and samples. You should document your audit findings, using facts, data, and examples, and classify them according to their severity and impact. You should also communicate your audit findings to the auditee and the audit team, using clear and constructive feedback.

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Eze Samson Chibueze, MS, MLS(ASCPi), AMAPH

Medical Laboratory scientist || CORU Reg. || IVD Field Application Specialist || Lead Auditor (ISO 9001:2015) || Biorisk Manager || Committed to Elevating Quality Standards in Medical Laboratory Diagnostics.
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Professionalism involves approaching the audit with a structured plan, respecting confidentiality, and maintaining a courteous demeanor. Objectivity requires auditors to remain impartial, basing evaluations on evidence rather than personal opinions. It involves a fair and unbiased assessment of compliance, considering both strengths and weaknesses. Professional and objective auditors foster an environment conducive to open communication, enabling a transparent exchange of information between auditors and auditees. This approach not only upholds the credibility of the audit process but also contributes to the overall improvement of Good Manufacturing Practices within the organization.

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4 Report and follow up on the audit results

After the audit, you should prepare a report that summarizes the audit objectives, scope, methods, findings, conclusions, and recommendations. You should ensure that the report is accurate, complete, and consistent, and that it reflects the audit evidence and the audit criteria. You should also ensure that the report is timely, concise, and clear, and that it meets the expectations and requirements of the auditee and the audit authority. You should also follow up on the audit results, by verifying the implementation and effectiveness of the corrective and preventive actions taken by the auditee, and by evaluating the performance and improvement of the auditee and the audit team.

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5 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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Eze Samson Chibueze, MS, MLS(ASCPi), AMAPH

Medical Laboratory scientist || CORU Reg. || IVD Field Application Specialist || Lead Auditor (ISO 9001:2015) || Biorisk Manager || Committed to Elevating Quality Standards in Medical Laboratory Diagnostics.
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Use risk-based sampling to focus on critical processes and products and ensure a representative sample that reflects the overall GMP compliance. Also develop a systematic follow-up process to track corrective actions and Monitor progress and re-audit as needed to verify sustained compliance. Finally, allocate time wisely, balancing depth and efficiency while Prioritizing findings based on severity to address critical issues promptly.

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Victoria Kudzorji - mMBA, BTech, HND

Quality Technical Lead || Bridging gaps between Products and End Users || 2024’Harvard Aspire Fellow|| R&D Chemist || Teaching & Mentoring || Passionate About Making The World a Safer Place for All??
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To ensure the most effective audit, define the purpose, scope, and objectives of a GMP audit. This allows the team to cover and thoroughly look into specific areas within the various processes and documents applicable to the audit structure, as well as the expected deliverables and follow-up actions. This helps to mitigate potential risks within the systems and sets clear communication goals for individuals involved.

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What are the most effective strategies for conducting timely and efficient GMP audits?

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3

4

5

1 Define the scope and objectives

2 Prepare a checklist and a plan

3 Conduct the audit professionally and objectively

4 Report and follow up on the audit results

5 Here’s what else to consider

Quality Management

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What are the most effective strategies for conducting timely and efficient GMP audits?

1

2

3

4

5

1 Define the scope and objectives

2 Prepare a checklist and a plan

3 Conduct the audit professionally and objectively

4 Report and follow up on the audit results

5 Here’s what else to consider

Quality Management

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