Good Laboratory Practices and Compliance Monitoring - Hardcover

Good Laboratory Practices and Compliance Monitoring

Hardcover. Zustand: New. This handbook is fully updated to the current regulatory requirement in the pharmaceutical laboratory world. Purpose of book is to assist individual on Gx Prequirement, good manufacturing practices, good laboratory practices, performance monitoring and root cause analysis and quality triangles The purpose of this hand book is to provide easily accessible knowledge about the good laboratory practices. In current pharmaceutical world we need a fast and reliable source of techniques to implement the system and resolve problem. This handbook gives pathway for us to take right decision. Nothing comes in one box for us. Changes happen with or without us. The higher we go in the organization, the more complex ore challenges become .This book gives overall view of quality laboratory system. We hope this handbook can contributes to assemble lots of related materials and package them in one place for easy reference and access. I encourage you to read, enjoy, study and learn from this book and go forth and empower you/ your teams to lead you and your organization to world class results. Contents: 1. Overview of Good Laboratory Practices in Pharmaceutical Industry 2. Overview of Good Microbiology Practices in Pharmaceutical Industry 3. Quality Assurance Management in GLP Environment 4. Laboratory Quality Manual 5. Laboratory Quality Policy 6. Laboratory Site Master Files 7. Validation Master Plan 8. Laboratory Computer-Software Validation and Qualification 9. Control of Spreadsheets in GLP 10. Analytical Instrument and Equipment Qualification 11. Electronic and Paper-Based Data Management in GLP 12. Laboratory Training and Qualification Management Program 13. Reviewer Qualification Management 14. Label Management in GLP Environment 15. Glassware Management in GLP 16. GLP Column Management 17. GLP Standard Operating Procedure (SOP) Management 18. GLP Specification Management 19. GLP Certificate o. Artikel-Nr. 139430

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