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...
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 guidance on the preparation of FAT and SAT documentation, including test protocols, aligned with Annex 15 (Validation/Qualification) of EU-GMP. A well-structured GMP order can significantly reduce challenges during subsequent validation and qualification processes. This book aims to equip you with the knowledge and skills to develop professional GMP orders and associated FAT/SAT exams. It covers essential topics such as structure, components, and creation processes. This resource is beneficial for professionals in pharmaceutical engineering, as well as students and trainees in chemistry, pharmaceutical industry, and pharmaceutical engineering. Additionally, the principles outlined in this book can be applied to other industries, including aerospace and electronics.
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