Six Sigma in the Pharmaceutical Industry

Six Sigma in the Pharmaceutical Industry
Author: Brian K. Nunnally
Publisher: CRC Press
Total Pages: 222
Release: 2007-06-13
Genre: Mathematics
ISBN: 1420054406

Six Sigma in the Pharmaceutical Industry is the first book to introduce the fundamentals of Six Sigma, examine control chart theory and practice, and explain the concept of variation management and reduction applied specifically to the pharmaceutical industry. The first half lays out a conceptual framework for understanding variation, while the second half introduces control chart theory and practice. Using case studies and statistics, the book illustrates the concepts and explains their application to actual workplace improvements. Providing the basis for a complete operating philosophy, this book focuses on core concepts and their implementation to improve the existing products and processes in the pharmaceutical industry.

Applying Lean Six Sigma in the Pharmaceutical Industry

Applying Lean Six Sigma in the Pharmaceutical Industry
Author: Bikash Chatterjee
Publisher: CRC Press
Total Pages: 171
Release: 2016-04-08
Genre: Business & Economics
ISBN: 1317180100

Bikash Chatterjee emphasizes the criticality of applying the principles of Lean and Six Sigma within the paradigm of the drug development process. His guide to operational excellence in the pharmaceutical and biotech industries is a focused summary of the application of Lean Six Sigma theory to the regulated life sciences. From molecule discovery to the application of PAT Applying Lean Six Sigma in the Pharmaceutical Industry will highlight the importance of framing these initiatives within the key deliverables of drug development manufacturing and quality. Challenging conventional wisdom the author offers a quality and efficiency perspective as a foundation for the principles of Quality by Design, PAT and the new philosophies underlying Process Validation. Each chapter includes discussion around the considerations for applying Lean manufacturing and Six Sigma principles and their tools, culminating in a case study to illustrate the application. The book is organized to reflect the major work centers involved in the drug development lifecycle. Each chapter is stand-alone but together they illustrate the necessary synergy between Lean, Six Sigma and compliance sensibilities required to be successful in the pharmaceutical industry. These design, manufacturing and management techniques are not without their challenges. Bikash Chatterjee's book offers the roadmap for an industry that is struggling to reinvent many of its development and business processes.

Statistical Methods for Six Sigma

Statistical Methods for Six Sigma
Author: Anand M. Joglekar
Publisher: John Wiley & Sons
Total Pages: 339
Release: 2003-09-19
Genre: Science
ISBN: 0471465372

A guide to achieving business successes through statistical methods Statistical methods are a key ingredient in providing data-based guidance to research and development as well as to manufacturing. Understanding the concepts and specific steps involved in each statistical method is critical for achieving consistent and on-target performance. Written by a recognized educator in the field, Statistical Methods for Six Sigma: In R&D and Manufacturing is specifically geared to engineers, scientists, technical managers, and other technical professionals in industry. Emphasizing practical learning, applications, and performance improvement, Dr. Joglekar?s text shows today?s industry professionals how to: Summarize and interpret data to make decisions Determine the amount of data to collect Compare product and process designs Build equations relating inputs and outputs Establish specifications and validate processes Reduce risk and cost-of-process control Quantify and reduce economic loss due to variability Estimate process capability and plan process improvements Identify key causes and their contributions to variability Analyze and improve measurement systems This long-awaited guide for students and professionals in research, development, quality, and manufacturing does not presume any prior knowledge of statistics. It covers a large number of useful statistical methods compactly, in a language and depth necessary to make successful applications. Statistical methods in this book include: variance components analysis, variance transmission analysis, risk-based control charts, capability and performance indices, quality planning, regression analysis, comparative experiments, descriptive statistics, sample size determination, confidence intervals, tolerance intervals, and measurement systems analysis. The book also contains a wealth of case studies and examples, and features a unique test to evaluate the reader?s understanding of the subject.

Validation of Pharmaceutical Processes

Validation of Pharmaceutical Processes
Author: James P. Agalloco
Publisher: CRC Press
Total Pages: 762
Release: 2007-09-25
Genre: Medical
ISBN: 1420019791

Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va

An Integrated Company-Wide Management System

An Integrated Company-Wide Management System
Author: Souraj Salah
Publisher: Springer
Total Pages: 247
Release: 2018-08-30
Genre: Technology & Engineering
ISBN: 3319990349

This book offers a comprehensive guide to implementing a company-wide management system (CWMS), utilising up-to-date methodologies of lean-six sigma in order to achieve high levels of business excellence. It builds the foundation for quality and continuous improvement, which can be implemented in any organization. The book begins with an introduction to and an overview of CWMSs, and reviews the existing literature on various management systems. It then discusses the integration and implementation of lean-six sigma in supply chain management. The integration approach presented highlights the link between the existing management systems and shows how continuous improvement methodologies are incorporated. The book then examines the components of CWMS, comparing them to other systems. It also explores Kano-based six sigma and concludes with further recommendations for reading. This book covers five management systems integrated into one novel approach that can be followed by organizations wishing to achieve quality and business excellence. Covering lean-six sigma – an essential element of management systems – it is a valuable resource for practitioners and academics alike.

What Is Six Sigma?

What Is Six Sigma?
Author: Peter S. Pande
Publisher: McGraw Hill Professional
Total Pages: 97
Release: 2001-11-16
Genre: Business & Economics
ISBN: 0071412700

A brief introduction to Six Sigma for employees Six Sigma is today's most talked-about system for improving the quality of organizational processes. Written by bestselling author Peter Pande,What Is Six Sigma? is a concise summary of the core themes and processes of Six Sigma. Unlike almost all other books on Six Sigma, it is written for the employees of organizations rolling out Six Sigmanot just managers. This helpful overview describes what Six Sigma is, why companies are implementing it, and how employees can make it a success in their own organizations. Based on the bestselling The Six Sigma Way, this accessable introduction to Six Sigma answers typical employee questions, concerns, and even skepticism about this revolutionary program. Includes: The six themes of Six Sigma A five-step roadmap to Six Sigma implementation The 10 basic tools of Six Sigma, with an entire page devoted to each

Lean Manufacturing and Six Sigma

Lean Manufacturing and Six Sigma
Author: Fausto Pedro García Márquez
Publisher: BoD – Books on Demand
Total Pages: 176
Release: 2020-02-14
Genre: Technology & Engineering
ISBN: 1789239079

Lean Manufacturing, also called lean production, was originally created in Toyota after the Second World War, in the reconstruction period. It is based on the idea of eliminating any waste in the industry, i.e. any activity or task that does not add value and requires resources. It is considered in every level of the industry, e.g. design, manufacturing, distribution, and customer service. The main wastes are: over-production against plan; waiting time of operators and machines; unnecessary transportation; waste in the process itself; excess stock of material and components; non value-adding motion; defects in quality. The diversity of these issues will be covered from algorithms, mathematical models, and software engineering by design methodologies and technical or practical solutions. This book intends to provide the reader with a comprehensive overview of the current state, cases studies, hardware and software solutions, analytics, and data science in dependability engineering.

Pharmaceutical Operations Management

Pharmaceutical Operations Management
Author: Pankaj Mohan
Publisher: McGraw-Hill Professional
Total Pages: 264
Release: 2006-03-16
Genre: Business & Economics
ISBN: 0071472495

Publisher's Note: Products purchased from Third Party sellers are not guaranteed by the publisher for quality, authenticity, or access to any online entitlements included with the product. This book brings together a winning team of international operations experts to set the framework for building a world-class manufacturing organization. Pharmaceutical Operations Management focuses on key concepts such as: Policy Execution, Risk Management, Supply chain modeling, Advance process control and Six Sigma for the pharmaceutical industry: critical techniques which will offset cost, increase efficiency and turn any manufacture into financial winner.

Industrial Pharmacy

Industrial Pharmacy
Author: Dr Muralidhar, Dr Narmada
Publisher: Notion Press
Total Pages: 281
Release: 2024-02-03
Genre: Medical
ISBN:

Industrial Pharmacy: From Pilot Plant to Market" is a comprehensive guide that provides practical approaches to pharmaceutical product development. With 37 exhaustive chapters, it covers important topics such as pilot plant scale-up techniques, technology transfer protocols, regulatory requirements, quality management systems, and Indian regulatory requirements. The book helps readers understand the significance of personnel requirements, space requirements, raw materials, and relevant documentation for solids, liquid orals, and semi-solids. It also provides insights into WHO guidelines for technology transfer, clinical research protocols, quality management concepts, ISO quality systems standards, and Indian regulatory requirements. This book is an essential resource for pharmaceutical professionals and students who seek to advance healthcare through innovative pharmaceutical product development.

Design for Six Sigma in Technology and Product Development

Design for Six Sigma in Technology and Product Development
Author: Clyde M. Creveling
Publisher: Prentice Hall Professional
Total Pages: 1011
Release: 2002-10-25
Genre: Technology & Engineering
ISBN: 0132797240

This book addresses many new topical areas for the development of 6 Sigma performance. The text is structured to demonstrate how 6 Sigma methods can be used as a very powerful tool within System Engineering and integration evaluations to help enable the process of Critical Parameter Management. The case studies and examples used throughout the book come from recent successful applications of the material developed in the text.