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Assessment Of Current Levels Of GMP against International Standards |
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Facility Design Review and qualifications of cleanrooms, watersystems, equipment |
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Procedure and Documentation Review |
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Validations of process, Cleaning and Analytical methods |
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Master Batch Record Review |
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Supplier / Vendor Quality Assurance Program |
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Third Party Audits |
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Periodic audits to verify compliance to defined systems. |
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Pre Inspection Audits. These can be targeted at particular regulatory bodies’ requirements |
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Guidance during regulatory audits. |
