Pharmaceutical Computer Systems Validation

Аннотация

Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system. Key topics in Pharmaceutical Computer Systems Validation, Second Edition include:GAMP5, ASTM 2500, EU GMP (Annex 11), and US GMP revisions to regulatory requirements for electronic records and signatures that should be published in 2008ICH Guidance Q8, Q9, and Q10 expectationsFDA cGMPs for the 21st Century Initiative and associated guidancePIC/S Guidance on Good Practice for Computerized Systems in GxP EnvironmentsWK9864 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipmentthe indirect developments from FDA/EU/Japan regulators and industrythe role of QA department, and internal and external suppliersthe integration of computer systems validation into single overall approach for wider systempractical guidance on handling common high, medium, and low risk issues that can occur during the life cycle of a computer systemmanaging outsource partners and handling legacy systemstopical issues uncovered by regulatory authorities including US FDA