Modern Aspects of Pharmaceutical Quality Assurance
portes grátis
Modern Aspects of Pharmaceutical Quality Assurance
Developing & Proposing Application models, SOPs, practical audit systems for Pharma Industry
Potdar, Manohar; Ghante, Minal; Bhusari, Vidhya
Springer Verlag, Singapore
03/2024
523
Dura
Inglês
9789819992706
15 a 20 dias
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Chater 1 Introduction: Quality Assurance from Perspective of Pharmaceutical Industry.- Chapter 2 Six-sigma Model in Pharma Industry (Part-I).- Chapter 3. Six-sigma Model in Pharma Industry (Part-II).- Chapter 4 Developing a practical audit system for a pharmaceutical industry based on six system inspection model.- Chapter 5.- Compliance Tools to Assist the Drug Industry for Regulatory Audits from Developed Countries.- Chapter 6 Developing an Application Model for Planning, Controlling, Improving and Assuring Quality for Pharmaceutical Industry - covering Quality Planning and Quality Control.- Chapter 7 Developing an Application model for Improving Quality for Pharmaceutical Manufacturing based on the Quality principle- covering Quality Improvement and Quality Assurance Audit.- Chapter 8 Developing a Design Qualification Protocol as Standard Operating Procedure for a Pharmaceutical Plant Facility Meeting cGMP requirement for Tablets andCapsule Manufacturing Department.- Chapter 9 Developing a Design Qualification Protocol as Standard Operating Procedure for a Pharmaceutical Plant Facility Meeting cGMP requirement for Liquid oral and Ointment Department.- Chapter 10 Developing a simplified model Standard Operating Procedure to implement quality metrics for Pharmaceutical Manufacturing System .- Chapter 11 Documentation and data integrity in Pharmaceutical Industry.- Chapter 12 Quality Risk Management. Chapter 13 Deviation, Change control and CAPA.
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Regulatory Audits;Guidance document;Plant layouts;Standard Operating Procedure;Pharmaceutical Manufacturing systems
Chater 1 Introduction: Quality Assurance from Perspective of Pharmaceutical Industry.- Chapter 2 Six-sigma Model in Pharma Industry (Part-I).- Chapter 3. Six-sigma Model in Pharma Industry (Part-II).- Chapter 4 Developing a practical audit system for a pharmaceutical industry based on six system inspection model.- Chapter 5.- Compliance Tools to Assist the Drug Industry for Regulatory Audits from Developed Countries.- Chapter 6 Developing an Application Model for Planning, Controlling, Improving and Assuring Quality for Pharmaceutical Industry - covering Quality Planning and Quality Control.- Chapter 7 Developing an Application model for Improving Quality for Pharmaceutical Manufacturing based on the Quality principle- covering Quality Improvement and Quality Assurance Audit.- Chapter 8 Developing a Design Qualification Protocol as Standard Operating Procedure for a Pharmaceutical Plant Facility Meeting cGMP requirement for Tablets andCapsule Manufacturing Department.- Chapter 9 Developing a Design Qualification Protocol as Standard Operating Procedure for a Pharmaceutical Plant Facility Meeting cGMP requirement for Liquid oral and Ointment Department.- Chapter 10 Developing a simplified model Standard Operating Procedure to implement quality metrics for Pharmaceutical Manufacturing System .- Chapter 11 Documentation and data integrity in Pharmaceutical Industry.- Chapter 12 Quality Risk Management. Chapter 13 Deviation, Change control and CAPA.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
