Download Free The Certified Pharmaceutical Gmp Professional Handbook Second Edition Book in PDF and EPUB Free Download. You can read online The Certified Pharmaceutical Gmp Professional Handbook Second Edition and write the review.

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.
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 is primarily meant to aid those taking the ASQ Certified Quality Engineer (CQE) exam and is best used in conjunction with The Certified Quality Engineer Handbook. Section 1 provides 380 practice questions organized by the seven parts of the 2015 Body of Knowledge (BOK). Section 2 gives the reader 205 additional practice questions from each of the seven parts, in a randomized order. For every question in both sections, detailed solutions are provided that explain why each answer is the correct one and also which section of the BOK the question corresponds to so that any further study needed can be focused on specific sections. A secondary audience is those taking exams for ASQ certifications whose BOKs’ have some crossover with the CQE. Namely, the Certified Six Sigma Black Belt (CSSBB), Certified Six Sigma Green Belt (CSSGB), Certified Reliability Engineer (CRE), and Certified Quality Inspector (CQI). Using this guide in studying for any of these exams would be extremely useful, particularly for the statistics portions of the BOKs. Unlike other resources on the market, all these questions and solutions were developed specifically to address the 2015 CQE Body of Knowledge and help those studying for it, including taking into account the proper depth of knowledge and required levels of cognition. None of this material has appeared in any previous resource or been shoehorned into fitting under the BOK’s topics. NOTE: Practice/sample test questions such as those in this study guide cannot be taken into ASQ certification exam rooms.
A comprehensive reference manual to the Certified Reliability Engineer Body of Knowledge and study guide for the CRE exam.
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.
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.
Risk elimination. Risk management. Risk mitigation. These terms are an increasingly important part of the lexicon of executive-level management as they strive to succeed in a business environment having global competition, geographically diverse suppliers, and new technologies. In this new, globally expansive marketplace, more than 50 percent of value creation is achieved outside of an organization’s walls, or, in other words, through their suppliers. This, too, is where the majority of product realization risk lies. This book defines what risk-based thinking is and how to apply it from the perspective of helping manage organizational risk through the supplier audit process. It provides a detailed and useful discussion of the practical application of risk-based supplier auditing principles. It can be a primer for those new to the profession of supplier auditing, and it also shares tips and best practices that would benefit experienced auditors as well. The first section explores supplier management, supplier auditing, and the supplier audit process. The second section discusses the skills, both traditional and nontraditional, needed to ensure a successful supplier audit. Relevant aspects of ASQ’s Certified Quality Auditor (CQA) and Certified Supplier Quality Professional (CSQP) Bodies of Knowledge are discussed in detail. The author’s friends and colleagues from around the globe shared their own stories in “Case in Point” vignettes interspersed throughout the book, providing first-hand case studies from, among others, the medical device, logistics, automotive, and aerospace industries.
The purpose of this new edition is to offer an updated view of the risk management field as it applies to medical products. Since the publication of the first edition (2012), the emphasis on risk-based processes has growth exponentially across all sectors, and risk management is now considered as significant as quality management. ISO 9001 was revised and now requires that top management promote the use of risk-based thinking. ISO 13485:2016, which specifies the requirements for a quality management system specific to the medical devices industry, also now shows a greater emphasis on risk management and risk-based decision making. In addition, the FDA Food Safety Modernization Act (FSMA) is the most important reform of U.S. food safety laws in more than 70 years. This indispensable book presents a systematic and comprehensive approach to quality risk management. It will assist medical and food product manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples. The appropriate use of quality risk management can facilitate compliance with regulatory requirements such as good manufacturing practice or good laboratory practice. All chapters have been updated and revised, and a new chapter has been added to discuss some of the most common pitfalls and misunderstandings regarding risk management, specifically those related to the use of FMEA as the only element of risk management programs. One of the appendices includes 12 case studies, and the companion CD-ROM contains dozens of U.S. FDA and European guidance documents as well as international harmonization documents (ICH and GHTF-IMDRF) related to risk management activities, as well as a 30-question exam (with answers) on the material discussed in the book.
For many years, we considered human errors or mistakes as the cause of mishaps or problems. In the manufacturing industries, human error, under whatever label (procedures not followed, lack of attention, or simply error), was the conclusion of any quality problem investigation. The way we look at the human side of problems has evolved during the past few decades. Now we see human errors as the symptoms of deeper causes. In other words, human errors are consequences, not causes. The basic objective of this book is to provide readers with useful information on theories, methods, and specific techniques that can be applied to control human failure. It is a book of ideas, concepts, and examples from the manufacturing sector. It presents a comprehensive overview of the subject, focusing on the practical application of the subject, specifically on the human side of quality and manufacturing errors. In other words, the primary focus of this book is human failure, including its identification, its causes, and how it can be reasonably controlled or prevented in the manufacturing industry setting. In addition to including a detailed discussion of human error (the inadvertent or involuntary component of human failure), a chapter is devoted to analysis and discussion related to voluntary (intentional) noncompliance. Written in a direct style, using simple industry language with abundant applied examples and practical references, this book's insights on human failure reduction will improve individual, organizational, and social well-being.