Author: Terry Jacobs
Publisher: CRC Press
ISBN: 1482258919
Category : Medical
Languages : en
Pages : 535
Get Book Here
Book Description
This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.
Author: Manohar A Potdar
Publisher:
ISBN: 9789385433764
Category : Business & Economics
Languages : en
Pages : 306
Get Book Here
Book Description
Designing, erection and commissioning of a pharmaceutical plant is a long drawn process. It needs basic understanding of pharmaceutical formulations and their logical and sequential processing. This whole process is tedious, time consuming and should have proper guidance in this regard. The book will provide such guidance which is a long felt need by the industry. Salient Features: - Pharmaceutical design aspects with sample layouts for all major formulations are discussed - All aspects related to project management, regulatory requirements, validation of facilities, HVAC and water system are discussed - A real handy book for all those who are involved in plant design, project management and facility and utilities validation in Pharmaceutical industry.
Author: Graham Cole
Publisher: CRC Press
ISBN: 113574355X
Category : Medical
Languages : en
Pages : 343
Get Book Here
Book Description
Pharmaceutical Production Facilities: Design and Applications considers the concepts and constraints that have to be considered in the design of small, medium and large scale production plants. The layout, along with the flow of materials and personnel through facilities are considered with reference to ensuring compliance with current good manufac
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309487811
Category : Medical
Languages : en
Pages : 69
Get Book Here
Book Description
On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030904491X
Category : Medical
Languages : en
Pages : 225
Get Book Here
Book Description
Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.
Author: Terry Jacobs
Publisher: CRC Press
ISBN: 1315355027
Category : Medical
Languages : en
Pages : 674
Get Book Here
Book Description
This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.
Author: Dr. Panos Chatzipanos
Publisher: Project Management Institute
ISBN: 1628255587
Category : Business & Economics
Languages : en
Pages : 297
Get Book Here
Book Description
Implementing Project Portfolio Management addresses the "how-tos" of portfolio management. It is designed for three primary audience groups: Business Executives, Portfolio Leaders and Practitioners, and Portfolio Thinkers. The authors provide insights on how to apply the performance management domains covered in the standard that are in practice today by introducing tools and templates into their discussion. Far-reaching in its impact on portfolio management practitioners, thinkers, stakeholders, and the wider project management community, this guide envisions the continued transformation of portfolio management with the changing needs of organizations and advances in technology.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309065313
Category : Medical
Languages : en
Pages : 216
Get Book Here
Book Description
Some people suffer from chronic, debilitating disorders for which no conventional treatment brings relief. Can marijuana ease their symptoms? Would it be breaking the law to turn to marijuana as a medication? There are few sources of objective, scientifically sound advice for people in this situation. Most books about marijuana and medicine attempt to promote the views of advocates or opponents. To fill the gap between these extremes, authors Alison Mack and Janet Joy have extracted critical findings from a recent Institute of Medicine study on this important issue, interpreting them for a general audience. Marijuana As Medicine? provides patientsâ€"as well as the people who care for themâ€"with a foundation for making decisions about their own health care. This empowering volume examines several key points, including: Whether marijuana can relieve a variety of symptoms, including pain, muscle spasticity, nausea, and appetite loss. The dangers of smoking marijuana, as well as the effects of its active chemical components on the immune system and on psychological health. The potential use of marijuana-based medications on symptoms of AIDS, cancer, multiple sclerosis, and several other specific disorders, in comparison with existing treatments. Marijuana As Medicine? introduces readers to the active compounds in marijuana. These include the principal ingredient in Marinol, a legal medication. The authors also discuss the prospects for developing other drugs derived from marijuana's active ingredients. In addition to providing an up-to-date review of the science behind the medical marijuana debate, Mack and Joy also answer common questions about the legal status of marijuana, explaining the conflict between state and federal law regarding its medical use. Intended primarily as an aid to patients and caregivers, this book objectively presents critical information so that it can be used to make responsible health care decisions. Marijuana As Medicine? will also be a valuable resource for policymakers, health care providers, patient counselors, medical faculty and studentsâ€"in short, anyone who wants to learn more about this important issue.
Author: Steven Ostrove
Publisher: Academic Press
ISBN: 0128175699
Category : Medical
Languages : en
Pages : 236
Get Book Here
Book Description
Equipment Qualification in the Pharmaceutical Industry provides guidance and basic information for the preparation of a quality qualification program. It has been noted that there is a general lack of understanding in the industry, especially for those new to the industry, as to what constitutes a compliant qualification program. Even experienced professionals have felt a lack of security in reaching a compliant state. This book outlines a guideline for the preparation and execution of qualification protocols including the installation (IQ), operational (OQ), and performance (PQ) protocols. It discusses the importance of related qualification programs (e.g., quality systems, commissioning, computer system, and cleaning) and how to incorporate them into a fully compliant qualification program. Furthermore, it provides matrices of what could be included in each type of protocol for major types of process equipment. While primarily for people entering the pharmaceutical industry, those established in the field will benefit from the multiple examples and matrices as well as integration of related systems. Equipment Qualification in the Pharmaceutical Industry provides students and pharmaceutical scientists a guideline for the preparation and execution of qualification (installation, operational, and performance) protocols. Incorporates good manufacturing processes into a compliant qualification program Provides examples of protocol layout Includes matrices for major process equipment, installation quality, operational quality, and performance quality requirements
Author: Ispe
Publisher:
ISBN: 9781936379989
Category :
Languages : en
Pages : 128
Get Book Here
Book Description
