The document outlines various types of audits, including product, process, and system audits, and emphasizes their importance in ensuring product quality and compliance with standards. It highlights the role of these audits in providing confidence in quality assurance systems and enabling timely problem resolution. The document details the objectives and methods associated with each type of audit.

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6. To ensure quality of the Product
To assess effectiveness of QA system.
It established high degree of confidence.
It permits timely correction of problems.
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7. Internal Audit
External Audit
Regulatory Audit
Product Audit
Process Audit
System Audit 7

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15. 4)Product Audit:
• An in-depth examination of a particular product to evaluate
whether it conforms to product specification, performance,
standards, and customer requirements.
5)Process Audit :
• An analysis of elements of a process and appraisal of
completeness, correctness of condition and probable
effectiveness.
6)System Audit :
• A documented activity perform to verify, by examination
and evalution of objective evidence, that applicable
elements of the quality system are suitable and have been
developed, documented and effectively implemented in
accordance with GMP. 15

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