GMP-/FDA/PICs ordering processes & FAT/SAT tests
Parviz Bayegi
Broschiertes Buch

GMP-/FDA/PICs ordering processes & FAT/SAT tests

For Pharma/Laboratory/Biotech/ATMP/Medical Device

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GMP Order Specifications (Requirement Specifications) are essential components of GMP validation and qualification documentation. To ensure compliance with EU-GMP/FDA/PICs regulations and URS (User Requirement Specifications) in pharmaceutical projects, these specifications must be developed in accordance with Good Documentation Practice (GDP). Upon completion of a GMP order, the customer may conduct Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), or both, depending on the scope and type of device or system, prior to final installation. This book provides comprehensive guidanc...