Download or read book Equipment Qualification in the Pharmaceutical Industry written by Steven Ostrove and published by Academic Press. This book was released on 2019-06-13 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Selection of Equipment for Equipment Qualification written by Kenneth G. Torr and published by . This book was released on 1989 with total page 42 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Pharmaceutical Equipment Validation written by Phil Cloud and published by CRC Press. This book was released on 1998-08-31 with total page 456 pages. Available in PDF, EPUB and Kindle. Book excerpt: While FDA regulations, cGMP, GLP, GCP, and the industry standard ISO 9000 require that documentation be established and followed, they do not provide guidelines on how to produce that documentation. Pharmaceutical Equipment Validation gives details on how to demonstrate compliance, what data to use, and how to produce the appropriate documentation. This book's user-friendly diagrams and other clear graphics illustrate key ideas throughout each protocol, offering a bird's-eye view of what is coming next-and they quickly guide you through the equipment validation. The author provides a thorough understanding of how to prepare, test, and complete equipment qualification protocols. He also explains how to perform qualification testing and whether to test the equipment for a worst case scenario. No other book deals exclusively with the key issues of equipment qualification and process validation for pharmaceutical process equipment-and provides instructions on how to achieve it. With pragmatic approach, this book includes 38 useful protocol templates, already completed, that provide instant answers to most protocol writing and testing questions. These templates cover specific equipment types, such, and provide accurate, industry acceptable equipment qualification protocols. Step-by-step, they show how to qualify each piece of equipment, and they provide a check for readers own protocols.

Download or read book Pharmaceutical Equipment Validation written by Phillip A. Cloud and published by . This book was released on 1998 with total page 443 pages. Available in PDF, EPUB and Kindle. Book excerpt: While FDA regulations, cGMP, GLP, GCP, and the industry standard ISO 9000 require that documentation be established and followed, they do not provide guidelines on how to produce that documentation. Pharmaceutical Equipment Validation gives details on how to demonstrate compliance, what data to use, and how to produce the appropriate documentation. This book's user-friendly diagrams and other clear graphics illustrate key ideas throughout each protocol, offering a bird's-eye view of what is coming next-and they quickly guide you through the equipment validation. The author provides a thorough understanding of how to prepare, test, and complete equipment qualification protocols. He also explains how to perform qualification testing and whether to test the equipment for a worst case scenario. No other book deals exclusively with the key issues of equipment qualification and process validation for pharmaceutical process equipment-and provides instructions on how to achieve it. With pragmatic approach, this book includes 38 useful protocol templates, already completed, that provide instant answers to most protocol writing and testing questions. These templates cover specific equipment types, such, and provide accurate, industry acceptable equipment qualification protocols. Step-by-step, they show how to qualify each piece of equipment, and they provide a check for readers own protocols.

Download or read book Cell Therapy written by Adrian Gee and published by Springer Science & Business Media. This book was released on 2009-09-18 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cell Therapy: cGMP Facilities and Manufacturing is the source for a complete discussion of facility design and operation with practical approaches to a variety of day-to-day activities, such as staff training and competency, cleaning procedures, and environmental monitoring. This in-depth book also includes detailed reviews of quality, the framework of regulations, and professional standards. It meets a previously unmet need for a thorough facility-focused resource, Cell Therapy: cGMP Facilities and Manufacturing will be an important addition to the cell therapy professional’s library. Additional topics in Cell Therapy: cGMP Facilities and Manufacturing...Standard operating procedures - Supply management - Facility equipment - Product manufacturing, review, release and administration - Facility master file.

Download or read book Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy written by Mahmoud Aljurf and published by Springer Nature. This book was released on 2021-02-19 with total page 181 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book provides a concise yet comprehensive overview on how to build a quality management program for hematopoietic stem cell transplantation (HSCT) and cellular therapy. The text reviews all the essential steps and elements necessary for establishing a quality management program and achieving accreditation in HSCT and cellular therapy. Specific areas of focus include document development and implementation, audits and validation, performance measurement, writing a quality management plan, the accreditation process, data management, and maintaining a quality management program. Written by experts in the field, Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy: A Practical Guide is a valuable resource for physicians, healthcare professionals, and laboratory staff involved in the creation and maintenance of a state-of-the-art HSCT and cellular therapy program.

Download or read book Equipment Qualification for Nuclear Installations written by IAEA and published by International Atomic Energy Agency. This book was released on 2021-12-09 with total page 73 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Safety Guide provides recommendations on a structured approach to the establishment and preservation of equipment qualification in nuclear installations, to confirm reliable performance of safety functions by such equipment during operational states and accident conditions, to avoid vulnerability due to common cause failure of the equipment. It applies primarily to equipment that performs one or more safety functions, but it may also be applied to items not important to safety, in accordance with national requirements. The qualification process covers electrical, instrumentation and control, and active mechanical equipment, and components associated with it, for example, seals, gaskets, lubricants, cables, connections, and mounting/anchoring structures. The qualification process for passive mechanical components for which the safety performance is assured by design in accordance with applicable codes, is outside the scope of this publication. The recommendations in this Safety Guide apply to new nuclear installations, and as far as is reasonably practicable to existing nuclear installations.

Download or read book How to Validate a Pharmaceutical Process written by Steven Ostrove and published by Academic Press. This book was released on 2016-06-07 with total page 219 pages. Available in PDF, EPUB and Kindle. Book excerpt: How to Validate a Pharmaceutical Process provides a “how to approach to developing and implementing a sustainable pharmaceutical process validation program. The latest volume in the Expertise in Pharmaceutical Process Technology Series, this book illustrates the methods and reasoning behind processes and protocols. It also addresses practical problems and offers solutions to qualify and validate a pharmaceutical process. Understanding the “why is critical to a successful and defensible process validation, making this book an essential research companion for all practitioners engaged in pharmaceutical process validation. Thoroughly referenced and based on the latest research and literature Illustrates the most common issues related to developing and implementing a sustainable process validation program and provides examples on how to be successful Covers important topics such as the lifecycle approach, quality by design, risk assessment, critical process parameters, US and international regulatory guidelines, and more

Download or read book The French Safety Approach Regarding Equipment Qualification written by J. Jalouneix and published by . This book was released on 1989 with total page 7 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Deficiencies in Equipment Qualification Testing and Certification Process written by and published by . This book was released on 1985 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Equipment Qualification in Operational Nuclear Power Plants written by International Atomic Energy Agency and published by . This book was released on 1998 with total page 138 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report is based on information presented at two IAEA Technical Committee meetings held within the framework of the IAEA Project on Operational Safety Guidance in 1993 and 1994. The document was prepared to provide guidance to Member States in assessing the status of equipment qualification (EQ) in operational nuclear power plants and in preserving this status. It offers methods and practices for activities which are necessary for a successful implementation of periodical safety reviews. The report should be of value for all countries that are parties to the Convention on Nuclear Safety, which entered into force on 24 October 1996 and stipulates the review and, where necessary, the upgrading of the safety of existing nuclear installations.

Download or read book Pharmaceutical Microbiological Quality Assurance and Control written by David Roesti and published by John Wiley & Sons. This book was released on 2020-01-02 with total page 594 pages. Available in PDF, EPUB and Kindle. Book excerpt: Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks

Download or read book Feasibility of an Equipment Qualificatiion Data Bank written by and published by . This book was released on 1980 with total page 81 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Similarity Principles for Equipment Qualification by Experience written by Daniel D. Kana and published by . This book was released on 1988 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Equipment Qualification EQ Risk Scoping Study written by and published by . This book was released on 1989 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book A Guide to Qualification of Electrical Equipment for Nuclear Power Plants written by and published by . This book was released on 1983 with total page 76 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book NRC Regulatory Guides written by U.S. Nuclear Regulatory Commission and published by . This book was released on 1973 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt: A compilation of currently available electronic versions of NRC regulatory guides.