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The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical industry driven by consumer expectations and regulatory oversight. This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.
The ASQ Certified Pharmaceutical GMP Professional Handbook assists candidates preparing for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and serves as a handy reference guide for practitioners in the field. This handbook covers compliance with good manufacturing practices (GMPs) as regulated and guided by national and international agencies for the pharmaceutical industry.
The Biomedical Quality Auditor Handbook was developed by the ASQ Biomedical Division in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the biomedical community. This third edition correlates to the 2013 exam Body of Knowledge (BoK) and reference list for ASQ’s Certified Biomedical Auditor program. It includes updates and corrections to errors and omissions in the second edition. Most notably it has been re-organized to align more closely with the BoK.
A comprehensive reference manual to the Certified Reliability Engineer Body of Knowledge and study guide for the CRE exam.
CGMP, Current Good Manufacturing Practices has legal and practical implications for manufacturers of medicinal products and medical devices. The requirements to meet CGMP is legal requirement but it also ensures the patient receives products that are safe, effective and of consistent quality. The FDA, WHO, ICH, PIC/s AND Eudralex provide extensive guidance and regulations on many topics related to the manufacture of medicinal and drug products. A large body of reference materials is available to manufacturers and engineering professionals. This book brings together the key requirements of GMP and briefly examines the common themes and requirements published by the various authorities, bodies and international organisations. The book includes the following chapters: Chapter 1-Overview of Good Manufacturing Practices Chapter 2-Quality Management Chapter 3-Personnel Chapter 4-Buildings and Facilities Chapter 5-Process Equipment Chapter 6-Documentation and Records Chapter 7-Materials Management Chapter 8-Rejection and re-use of materials Chapter 9-Validation Chapter 10- Change Control Chapter 11-Complaints and recalls Page count 160. Paperback book. Large 8" x 10" format.
This book was written to aid quality technicians and engineers. It is a result of 30 years of quality-related work experience. To that end, the intent of this book is to provide the quality professional working in virtually any industry a quick, convenient, and comprehensive guide to properly conducting design of experiments (DOE) for the purpose of process optimization. This is a practical introduction to the basics of DOE, intended for people who have never been exposed to design of experiments, been intimidated in their attempts to learn about DOE, or have not appreciated the potential of this family of tools in their process improvement and optimization efforts. In addition, this book is a useful reference when preparing for and taking many of the ASQ quality certification examinations, including the Certified Quality Technician (CQT), Certified Six Sigma Green Belt (CSSGB), Certified Quality Engineer (CQE), Certified Six Sigma Black Belt (CSSBB), and Certified Reliability Engineer (CRE).
This book — a result of 30 years of quality-related work experience — was written to aid quality technicians and engineers. It provides the quality professional working in virtually any industry a quick, convenient, and comprehensive guide to properly conducting measurement systems analysis (MSA). The intent of this book is to provide background and examples on the application of gage R&R methodology (test method validation) for variable and attribute data, help for those who work with devices that don’t fit the usual approach, and ideas for measurement devices that require innovation to assess their performance under off-line, static conditions. The ultimate objective is to determine how best to improve the control and performance of a process. The reader is assumed to be familiar with basic control charting methodology since assessment of statistical control of the measurement process is important. One may wonder why performing a gage R&R is so important; the simple answers are profit, public health, and safety. Companies that are shipping product that is out of specification can be subjected to expensive litigation, especially in the aviation, pharmaceutical, and medical device industries. This book will be a useful reference when preparing for and taking many of the ASQ quality certification examinations, including the Certified Quality Technician (CQT), Certified Calibration Technician (CCT), Certified Quality Inspector (CQI), Certified Six Sigma Green Belt (CSSGB), Certified Quality Engineer (CQE), Certified Six Sigma Black Belt (CSSBB), and Certified Reliability Engineer (CRE).
This book was written to aid quality technicians and engineers. It is a compilation of 30 years of quality-related work experience and the result of frustration at the number of books necessary, at times, to provide statistical support. To that end, the intent of this book is to provide the quality professional working in virtually any industry a quick, convenient, and comprehensive guide to properly utilize statistics in an efficient and effective manner. This book will be a useful reference when preparing for and taking many of the ASQ quality certification examinations, including the Certified Quality Technician (CQT), Certified Six Sigma Green Belt (CSSGB), Certified Quality Engineer (CQE), Certified Six Sigma Black Belt (CSSBB), and Certified Reliability Engineer (CRE). This book is an expansion of the work of Robert A. Dovich in his books Quality Engineering Statistics and Reliability Statistics. It builds on and expands Dovich's method of presenting statistical applications in a simple, easy-to-follow format.
This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.