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2021
Guidance 007 – Analytical Test Method Validation – Robustness
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Guidance 006 – Analytical Test Method Validation – Linearity, Range and Specificity
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Guidance 005 – Analytical Test Method Validation – Quantitation and Detection Limit
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Guidance 004 – Analytical Test Method Validation – Precision and Accuracy
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Guidance 003 – Analytical Test Method Validation – System Suitability
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Guidance 002 – Analytical Test Method Validation – Risk Assessment and Prioritization
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Manual – 032 R&D QA Audits for Suppliers and Vendors
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MAN-125 Component Return Procedure From Packaging Floor
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MAN-120 Finished Pack Sampling by Production Personnel
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MAN-115 Machine Start up Challenges and In-Process Testing Procedures
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MAN-110 Example of Operation of automatic Checkweigher for Finished Packs
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MAN-100 Weighing Equipment – Checking and Calibration
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MAN-095 Vacuum Leak Testing Procedure forFinished Goods
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TEMPLATE-310 Impact Assessment Template for Equipment, Utility and Computer
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TEMPLATE-305 Electronic Records and Signatures Compliance Assessment
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TEMPLATE-300 Product Transfer Protocol Template
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TEMPLATE-295 Process Validation Report Template
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TEMPLATE-290 Process Validation Protocol template
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