Basics of Pharmaceutical Manufacturing and Quality Operations
portes grátis
Basics of Pharmaceutical Manufacturing and Quality Operations
A Comprehensive Guide
Usmani, Shahid Bader; Asif, Erfan Syed
Taylor & Francis Ltd
03/2024
254
Dura
Inglês
9781032432052
15 a 20 dias
Descrição não disponível.
Preface
Chapter 1 Good Manufacturing Practice (GMP), Good Lab Practice (GLP) and Good Documentation Practice (GDP)
Chapter 2 Concept of Calibration
Chapter 3 Reference Standards and Reagents
Chapter 4 Chemical Tests
Chapter 5 Physical Testing of Raw Materials, Intermediate, and Finished Products
Chapter 6 Data Integrity
Chapter 7 Process Validation
Chapter 7.1 Protocol Generation
Chapter 7.2 Sampling and Testing Plan
Chapter 7.3 Process Validation Report Writing
Chapter 8 Cleaning Validation
Chapter 9 Method Development and Method Validation
Chapter 10 Qualification and Its Segments
Chapter 10.1 User Requirement Specification
Chapter 10.2 Functional Specification
Chapter 11 Stability Studies, Stability Indicating,and Methods Degradates
Chapter 12 Technology Transfer
Chapter 13 Dispensing
Chapter 14 Production
Chapter 15 Packaging
Chapter 16 Role of Quality Assurance
Chapter 17 Role of Quality Control
Chapter 18 Logistics - Cold Chain Supply Chapter 19 GMP for Biologics and Similar Medicines
Chapter 20 QA/QC Release
Index
Chapter 1 Good Manufacturing Practice (GMP), Good Lab Practice (GLP) and Good Documentation Practice (GDP)
Chapter 2 Concept of Calibration
Chapter 3 Reference Standards and Reagents
Chapter 4 Chemical Tests
Chapter 5 Physical Testing of Raw Materials, Intermediate, and Finished Products
Chapter 6 Data Integrity
Chapter 7 Process Validation
Chapter 7.1 Protocol Generation
Chapter 7.2 Sampling and Testing Plan
Chapter 7.3 Process Validation Report Writing
Chapter 8 Cleaning Validation
Chapter 9 Method Development and Method Validation
Chapter 10 Qualification and Its Segments
Chapter 10.1 User Requirement Specification
Chapter 10.2 Functional Specification
Chapter 11 Stability Studies, Stability Indicating,and Methods Degradates
Chapter 12 Technology Transfer
Chapter 13 Dispensing
Chapter 14 Production
Chapter 15 Packaging
Chapter 16 Role of Quality Assurance
Chapter 17 Role of Quality Control
Chapter 18 Logistics - Cold Chain Supply Chapter 19 GMP for Biologics and Similar Medicines
Chapter 20 QA/QC Release
Index
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
pharmaceutical validation;process qualification;data integrity compliance;analytical method development;cleaning validation procedures;stability testing pharmaceuticals;pharmaceutical quality systems training
Preface
Chapter 1 Good Manufacturing Practice (GMP), Good Lab Practice (GLP) and Good Documentation Practice (GDP)
Chapter 2 Concept of Calibration
Chapter 3 Reference Standards and Reagents
Chapter 4 Chemical Tests
Chapter 5 Physical Testing of Raw Materials, Intermediate, and Finished Products
Chapter 6 Data Integrity
Chapter 7 Process Validation
Chapter 7.1 Protocol Generation
Chapter 7.2 Sampling and Testing Plan
Chapter 7.3 Process Validation Report Writing
Chapter 8 Cleaning Validation
Chapter 9 Method Development and Method Validation
Chapter 10 Qualification and Its Segments
Chapter 10.1 User Requirement Specification
Chapter 10.2 Functional Specification
Chapter 11 Stability Studies, Stability Indicating,and Methods Degradates
Chapter 12 Technology Transfer
Chapter 13 Dispensing
Chapter 14 Production
Chapter 15 Packaging
Chapter 16 Role of Quality Assurance
Chapter 17 Role of Quality Control
Chapter 18 Logistics - Cold Chain Supply Chapter 19 GMP for Biologics and Similar Medicines
Chapter 20 QA/QC Release
Index
Chapter 1 Good Manufacturing Practice (GMP), Good Lab Practice (GLP) and Good Documentation Practice (GDP)
Chapter 2 Concept of Calibration
Chapter 3 Reference Standards and Reagents
Chapter 4 Chemical Tests
Chapter 5 Physical Testing of Raw Materials, Intermediate, and Finished Products
Chapter 6 Data Integrity
Chapter 7 Process Validation
Chapter 7.1 Protocol Generation
Chapter 7.2 Sampling and Testing Plan
Chapter 7.3 Process Validation Report Writing
Chapter 8 Cleaning Validation
Chapter 9 Method Development and Method Validation
Chapter 10 Qualification and Its Segments
Chapter 10.1 User Requirement Specification
Chapter 10.2 Functional Specification
Chapter 11 Stability Studies, Stability Indicating,and Methods Degradates
Chapter 12 Technology Transfer
Chapter 13 Dispensing
Chapter 14 Production
Chapter 15 Packaging
Chapter 16 Role of Quality Assurance
Chapter 17 Role of Quality Control
Chapter 18 Logistics - Cold Chain Supply Chapter 19 GMP for Biologics and Similar Medicines
Chapter 20 QA/QC Release
Index
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
