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Question 1 of 30
BioPharm Solutions, a pharmaceutical company based in the United Kingdom, is implementing ISO 10005:2018 to enhance its quality management system. The company recognizes the importance of internal audits in maintaining compliance with GMP regulations and ensuring the quality of its products. Considering the requirements of ISO 10005:2018, which of the following approaches would be most effective for BioPharm Solutions to conduct internal audits, ensuring their effectiveness in identifying areas for improvement and maintaining compliance? This approach should address the purpose and scope of internal audits, audit planning and preparation, conducting internal audits, reporting audit findings, and follow-up and corrective actions.
Define audit objectives and scope, develop an audit plan, gather evidence through interviews and document reviews, report audit findings, and develop corrective action plans to address non-conformities.
Conduct infrequent and superficial audits, focus primarily on verifying compliance with GMP regulations, neglect to report audit findings, and fail to develop corrective action plans.
Outsource all internal audit activities to external providers without establishing internal control procedures, limit the scope of audits to specific departments, and conduct audits without a defined audit plan.
Conduct audits without proper training or qualifications, rely solely on self-assessment for identifying non-conformities, and neglect to follow up on audit findings.

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