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Achieving Quality and Compliance Excellence in Pharmaceuticals
Madhu Raju Saghee

Book Code: PHCOM50030
Availability Status: IN STOCK
Edition: 1st Edition 2012
ISBN: 9788190646789
Presentation: 664 pages, Hardbound
Book Price in US $
Book Price in EURO
USD 195.00
EURO 160.00
Contents of the Book:

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In todays contemporary pharmaceutical industry, the focus has slowly but surely shifted from the elusive research pipeline and latest blockbuster molecules to current processes, efficiencies and manufacturing systems. A path most often taken by manufacturers today in this direction includes improving their overall quality and compliance efforts. This results in a two-pronged approach of minimizing the litigation cost and concurrently improving the overall quality of the products and efficiencies in their processes and procedures. This book provides current thinking and approaches to achieving quality and compliance from top industry experts and is pioneering in bringing this wealth of information together in a single volume which will be of great use to the pharmaceutical industry. Compliance and quality issues have been comprehensively covered, from GMP requirements to deviation management, OOS and CAPA methodologies, QRM and QMS practical implementation, qualification and validation, records and documentation practices, latest GMP training techniques and performance metrics for compliance and detailed analysis of ICH guidelines for practical implementation.


This book aligns with the FDA’s 21st century initiative and the ICH guidelines focused on quality risk management (ICH Q8, Q9, Q10 and Q11) and underpins the importance of science based decisions and risk evaluation as the centerpiece of compliance policy and execution. It provides a pragmatic framework for establishing a robust quality system.

About the Editor

Madhu Raju Saghee is working in corporate quality department at Gland Pharma. His areas of expertise include all aspects of quality and compliance for systems, processes, facilities and operations for drug products, particularly for sterile products. Madhu is also a volunteer for Pharmaceutical and Healthcare Sciences Society (PHSS) and acts as Director for Indian region. Madhu is the co-editor of the books ''Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices'' and ''Cleanroom Management in Pharmaceuticals and Healthcare.'' Madhu has a Master of Science in Microbiology. He is an active member of various industry associations, including PDA, PHSS and ISPE.

CONTENTS

1    Fundamentals of Global GMP Requirements
      by Atul Shirgaonkar

      Introduction
      What are GMPs
      History and Evolution of GMPs
      Major International GMPs
      Quality Management
      Product Quality Review
      Quality Risk Management
      GMP: Differences between US FDA and EU
         Requirements
      Conclusion
      References
         
2    Effective CAPA Management for Optimal
         Compliance
      by Michael Hopper

      Introduction
      Examples of CAPA Issues
      Global 8D
      Human Error
      Approaches to CAPA
      Summary
      References
      
3    Laboratory Compliance and Handling Out-of-
         Specification (OOS) Results in the Laboratory
      by John Lanese and A.V. Prabhu

      Laboratory Controls
      Handling Out of Specification (OOS) Results
      Phase I of the OOS Investigation
      Phase II of the OOS Investigation
      Conclusion
      References
      
4    Effectively Incorporating Quality Risk
     
Management into Quality Systems
      by Tim Sandle and Sanjit Singh Lamba

      Introduction
      Quality Systems
      Guidelines
      Anatomy of ICH Q9
      Applying Quality Risk Management
      The Basics of Risk Assessment
      Risk Assessment Tools
      The Integration of QRM into Some Process Quality
         Systems
      Advantages and Disadvantages of Risk Assessment
      Conclusion
      References
        
5    Monitoring and Controlling Process Drift for
         Enhancing Quality
      by Nandkumar Chodankar

      Introduction
      Definition of Process Drift
      Chance Cause
      Background of Process Development and Process
         Validation
      Process Variables (Identified Chance Cause)
      Combined Effect of Variables
      What Could be the Additional Causes for Process
         Drift
      Categorizing Process Drift
      Approaches to Developing a Control Strategy
      Steady State Concept
      Development of Critical Strategy for Process
         Modelling Control Design
      PAT: A Tool for Online Process Control
      Steps involved in API Manufacturing and Their
         Control
      Steps involved in Drug Product Manufacturing and
         Their Control
      Summary
      References
        
6    Qualification and Validation
      by Tim Sandle

      Introduction
      Regulations
      History of Validation
      Validations Concepts and Documentation
      Risk Based Approaches to Validation
      Re-Validation Requirements
      Different Types of Validation: Case Studies
      Conclusion
      References
        
7    Process Validation
      by Mark F. Witcher

      Introduction
      History of Manufacturing Controls & Process
         Validation
      Design Space - Defining and Describing the
         Manufacturing Process
      FDA''s 2011 Validation Paradigm
      Product Lifecycle
      The Role of QbD in Process Validation
      Understanding the Process Validation Paradigm
      Using the Process Validation Paradigm
      Quality Risk Management (QRM) for Process
         Validation
      Legacy Products
      Validation Master Plan (VMP)
      References
        
8    Documents, Records, and Part 11 Compliance
      by Janet Gough

      Introduction
      Documentation and Regulation
      The Document Continuum
      Features of Robust Systems
      Part 11
      Deciding to go Electronic
      System Documentation
      Maintaining Compliance and Inspection Readiness
      References
       
9    Change Control and Management
      by R. Raghunandanan

      Introduction
      Key Definitions
      Categorization of Different Changes
      Why Change Control
      Regulatory Requirements
      GMP Requirements
      Business Requirements
      Change Control Management Process
      Documentation
      Example of FDA Warning Letter
      References
        
10  Deviation Management
      by Alicia Tébar Pérez

      Introduction
      Deviations - Regulatory Framework
      What Constitutes a Deviation
      Deviation Management Flowchart
      Deviations into the Quality System
      Common Deficiencies Related to Poor Deviation
         Management
      Deviation Management from a Risk/Science Based
         Perspective
      Applying Risk Analysis to Deviation Management
      Deviations and Knowledge Management for
         Continuous Improvement
      Advanced Tools for Deviation Management
         and Reduction
      Conclusions
      Acknowledgements
      References
        
11  Internal Quality Assessments/Self-Audits
      by R. Raghunandanan

      Introduction
      Key Definitions
      Why Internal Quality Audits
      Regulatory Requirements
      Who Carries Out Audits
      Auditor Requisites
      Auditing Process
      Reporting and CAPA
      Why Audits Fail
      Need to Strengthen Internal Audit System
        
12  Designing an Effective GMP Training Program
      by David Markovitz

      Introduction
      GMP Training is a Process
      GMP Training - A Process to Ensure Compliance
      Proper Preparation for Effective GMP Training
      Conducting Effective GMP Training: Dos and Donts
         for Success
      Effective Followup Strategiesto GMP Training
      Start with the Basics
      Conclusion
     
13  Behavioural GMPS (bGxP®): A New Paradigm
         in Compliance Management
      by Brian Szukala

      Introduction: Challenges Facing the Industry
      Surviving in a World of ''Non-Compliance''
      Origins of bGxP
      The Concept of Behavioural Compliance
      Drivers for Behavioural Change - PIMS Model
      First Step in the Process - The ICE Audit
      Human Error and bbCi
      Sustaining the Change and Future Developments
         in GxP
      References
        
14  Supplier Quality Management
      by Ajit Basrur and David Stephon

      Introduction
      Government Regulatory Drivers
      Applicable Regulations/Guidelines
      Supplier Controls
      Sub Tier Suppliers
      References
      Key Terms
        
15  Understanding the United States Pharmacopeia
         (USP)
      by Robert D. Seltzer

      Introduction
      General Notices
      Mandatory USP General Chapter Key Takeaways
      Informative USP General Chapter Key Takeaways
      Acknowledgements
      References
 
16  Spotting Overall Weak GMP Compliance
         Systems
      by Robert D. Seltzer

      Introduction
      Key Definitions, Fallacies in Logic and GMP
         Literacy
      Risk Categorized and Semi-Quantified
      Trigger Events for Investigation, Remediation and
         Corrective Action
      Causes and Effects
      Product Quality Complaints
      Corrective Action Completeness and Effectiveness
      Concluding Remarks and Examples
      Acknowledgements
      References
        
17  Meaningful Performance Metrics for
         Compliance
      by Roger Janczak

      Overview of Performance Metrics
      Principles of Establishing Performance Metrics for
         Compliance
      Compliance Metrics
      Reviews, Scorecards and Dashboards
      Other Considerations
      References
        
18  Implementing ICH Q 10: A Pragmatic Approach
      by Alok Ghosh and Nilanjana Basu

      Introduction: What is ICH Q10
      Key Messages of ICH Q10
      Roles and Responsibilities of Senior Management
      Product Lifecycle Covered by PQS
      Continual Improvement
      Enablers of PQS
      Manufacturing Implementation & PQS
      Conclusive Remarks
      Acknowledgement
      References
        
19  Compliance Aspects of APIs Manufacturing
      by Richard Einig

      Introduction
      Quality Management and Personnel
      Facilities, Equipment and Utilities
      Production
      Laboratory Control and Stability Studies
      Conclusion
      References
        
20  Compliance Aspects of Sterile Manufacturing
      by Tim Sandle and Madhu Raju Saghee

      Introduction
      Sterility
      Methods of Producing Sterile Products
      A Brief History of Compliance Pertaining to Sterile
         Products
      Compliance Aspects of Sterile Manufacturing
      Important Compliance Issues
      Summary
      References

21  Domestic and International U.S. Food and Drug
      Administration (FDA) Inspections
      by Robert D. Seltzer

      Introduction
      Types of Inspections
      Inspections of Foreign Drug Manufacturers
      Inspection Techniques
      FDA Inspection Preparedness and Handling
      Implications from FDA''s Admission to the PIC
      Acknowledgements
      References
        
22  Avoiding FDA Enforcement Actions:  An
         Optimal & Sustainable Compliance Program
      by Areta Kupchyk

      Introduction
      FDAs Legal Authority
      FDA Enforcement
      Post Approval Requirements, Compliance,
         and Enforcement
      Other FDA Compliance and Enforcement Methods
         Tools
      Concusions and Recommendations
        
23  Developing a Master QMS Plan
      by John E. Lincoln

      Introduction
      Development of "Quality" in the 21st Century
      Master QMS Plan - Product Use Risk Based
      Developing a Master QMS Plan
      Quality Systems at US FDA and EU
      Modern Quality Systems
      A Pragmatic Framework for Building a Culture of
         Compliance
      Conclusion
        
24  Trends in cGMP Compliance
      by Mitch Manning

      Introduction
      What are Trends in GMP Compliance
      Why Identify GMP Compliance Trends
      How to Identify and Use GMP Compliance Trends
      Conclusion: Trends in GMP Compliance
      References
        
      Index


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