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 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 Pharmaceutical Calibration Validation and Qualification A Comprehensive Approach written by Shiv Shankar Shukla and published by Springer Nature. This book was released on 2023-02-14 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: This up-to-date and unique monograph covers the different aspects of pharmaceutical validation, calibration, qualification and documentation. It discusses the various methods and processes under all these heads. It includes eight major sections and exhaustively covers each topic.The book includes interesting and timely topics like the ‘Validation of herbals’ considering the increasing reliance on herbal medicines. It includes a section of validation of dosage forms, which is an essential topic for any pharmaceutical scientist. The chapters provide lucid illustrations, figures, flowcharts and other diagrams to facilitate understanding. A final section on 'expert opinion' provides a rundown about the global scenario to the readers. The book serves as a complete reference material for students, researchers and industry experts in the field of pharmaceutical sciences, medicinal chemistry and pharmacology.

Download or read book Validation Standard Operating Procedures written by Syed Imtiaz Haider and published by CRC Press. This book was released on 2006-05-30 with total page 1144 pages. Available in PDF, EPUB and Kindle. Book excerpt: Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluati

Download or read book Guideline on General Principles of Process Validation written by and published by . This book was released on 1987 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Practical Approaches to Method Validation and Essential Instrument Qualification written by Chung Chow Chan and published by John Wiley & Sons. This book was released on 2011-03-01 with total page 363 pages. Available in PDF, EPUB and Kindle. Book excerpt: Practical approaches to ensure that analytical methods and instruments meet GMP standards and requirements Complementing the authors' first book, Analytical Method Validation and Instrument Performance Verification, this new volume provides coverage of more advanced topics, focusing on additional and supplemental methods, instruments, and electronic systems that are used in pharmaceutical, biopharmaceutical, and clinical testing. Readers will gain new and valuable insights that enable them to avoid common pitfalls in order to seamlessly conduct analytical method validation as well as instrument operation qualification and performance verification. Part 1, Method Validation, begins with an overview of the book's risk-based approach to phase appropriate validation and instrument qualification; it then focuses on the strategies and requirements for early phase drug development, including validation of specific techniques and functions such as process analytical technology, cleaning validation, and validation of laboratory information management systems Part 2, Instrument Performance Verification, explores the underlying principles and techniques for verifying instrument performance—coverage includes analytical instruments that are increasingly important to the pharmaceutical industry, such as NIR spectrometers and particle size analyzers—and offers readers a variety of alternative approaches for the successful verification of instrument performance based on the needs of their labs At the end of each chapter, the authors examine important practical problems and share their solutions. All the methods covered in this book follow Good Analytical Practices (GAP) to ensure that reliable data are generated in compliance with current Good Manufacturing Practices (cGMP). Analysts, scientists, engineers, technologists, and technical managers should turn to this book to ensure that analytical methods and instruments are accurate and meet GMP standards and requirements.

Download or read book Basics of Pharmaceutical Manufacturing and Quality Operations written by Erfan Syed Asif and published by CRC Press. This book was released on 2024-03-14 with total page 267 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides guidance on how to meet the requirements of the pharmaceutical industry as a beginner. It includes procedures for production and packaging, batch auditing as well as all quality measures used in the pharmaceutical industry. This book also provides questions and answers with each chapter for institutes and trainers providing basic training to the new graduates and new comers to the industry. Basics of Pharmaceutical Manufacturing and Quality Operations: A Comprehensive Guide is primarily written for anyone in the pharmaceutical industry interested in development and manufacturing of active pharmaceutical ingredient (API) and finished pharmaceutical manufacturers in both sterile and non‐sterile areas. The book is a simple, concise, and easy to use reference tool covering basic quality concepts required by the pharmaceutical educational institutions and professional certification bodies. It describes details of all GXP activities that are directly related to Quality, Safety, and Efficacy of the products manufactured under the umbrella of Quality Operations, common testing methods which are used in any modern industry, Requirements of Validation and Qualification of equipment, facilities and processes, integral segments of Drug product manufacturing, storage, and distribution practices. The material provides stepwise guidance on how to evaluate, audit, qualify, and approve a pharmaceutical product to enhance the GMP within the industry. The book is written with the idea of providing basic knowledge to undergraduate students who are preparing to enter the industry at the end of their graduation. The book would also be beneficial for institutions conducting pharmaceutical technology study courses in terms of GMP and GLP applications. Features: Provides readers and front line health care product manufacturers, all the information they need to know to develop a GMP oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements. Provides stepwise guidance on how to evaluate, audit, qualify, and approve a pharmaceutical product and packaging material to enhance the GMP within the industry. Includes significant processes and steps in production for all common dosage forms. Explains how in‐process and finished products are released. Provides an ideal and effective tool for anyone starting Quality Assurance/Quality control/Production responsibilities.

Download or read book Facility Validation written by Graham C. Wrigley and published by CRC Press. This book was released on 2004-03-29 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt: Often considered a necessary evil by the pharmaceutical industry, validation is still understood by many as unrestrained bureaucracy, paperwork, and procedures whose roots and logic are obscure and only serve to slow down progress. Thoroughly defining the philosophy, application, and processes, Facility Validation: Theory, Practice, and Tools explo

Download or read book Equipment Qualification of Ion Mobility Spectrometry and Method Development and Validation for Pharmaceutical Equipment Cleaning Validation written by Amy Lee Heiser and published by . This book was released on 2012 with total page 51 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ion mobility spectrometry (IMS) instrumentation has been identified as a suitable technology for the detection and reporting of drug product and detergent residues from pharmaceutical manufacturing equipment. Ion mobility is not a new technology, but is entering the field of cleaning validation because of tightened requirements from the US Food and Drug Administration (FDA). The purpose of this thesis is to outline a practical implementation of the analytical technique, Ion Mobility Spectrometry in a cleaning validation program. Ion Mobility Spectrometry (IMS) is fast and specific for the analysis of small organic molecules and has been gaining popularity in the pharmaceutical industry. The challenge in the implementation of any new analytical technique in a pharmaceutical laboratory is establishing suitable methodology and this thesis will outline the steps taken for developing and validating a method for detection of the antihistamine drug Loratadine. The author will also provide a detailed introduction to the requirements of equipment qualification, cleaning validation and analytical method validation programs in the pharmaceutical industry.

Download or read book Pharmaceutical Computer Systems Validation written by Guy Wingate and published by CRC Press. This book was released on 2016-04-19 with total page 773 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.

Download or read book How to Sell Validatable Equipment to Pharmaceutical Manufacturers written by Erik Kopp and published by CRC Press. This book was released on 1999-09-30 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: Suppliers of pharmaceutical manufacturing equipment must ensure that their equipment is provided to their customers in a validatable state. Written in simple, clear, and concise language that gets past all the regulationese, this book covers the basics of validation, planning process equipment design and construction, documentation requirements, avoiding validation pitfalls, and the types of services the supplier should provide. The book provides insights on how to avoid the costly and time-consuming problem of reworking the equipment to develop the information that is needed to successfully complete their validation package - after the equipment has been delivered and installed. Here in one volume is all the information suppliers and manufacturers need to be able to effectively conduct business in a cost- and time-effective manner. Key areas of discussion include: o Validation and GMP issues o Why validation is so important to pharmaceutical manufacturers o The role of equipment suppliers in supporting validation o How validation affects the quality of drugs o A discussion of the importance of each phase of validation o Examples of pre-validation work o Pharmaceutical industry conventions for equipment design & construction o Questions to ask about validation, including a checklist o Regulations in plain language, including the terms and vocabulary o Computer validation o Business & cost issues

Download or read book Jump Starting a Career in Pharmaceuticals written by Tamra B. Orr and published by The Rosen Publishing Group, Inc. This book was released on 2013-12-15 with total page 82 pages. Available in PDF, EPUB and Kindle. Book excerpt: For readers interested in becoming a pharmacy technician, manufacturing technician, pharmaceutical sales representative, pharmacy billing specialist, pharmacy records manager, or pharmacy clerk, among other jobs, this guide encourages them to start doing their homework now by taking any high school, honors, college prep, or community college science and math classes available. Invaluable information regarding job training, certification, and associate's degrees is provided. The relative merits and advantages of online, community college, traditional university, and 2- and 4-year programs are analyzed and discussed. Networking is also emphasized. This valuable volume will help direct readers to a great pharmaceutical industry career.

Download or read book Quality assurance of pharmaceuticals a compendium of guidelines and related materials Volume 2 Good manufacturing practices and inspection written by World Health Organization and published by World Health Organization. This book was released on 2024-01-31 with total page 1354 pages. Available in PDF, EPUB and Kindle. Book excerpt: The GMP Compendium for Medical Products is a valuable resource for manufacturers, regulators, and other stakeholders involved in producing and distributing medical products. It covers various topics, from quality management systems to personnel hygiene, equipment validation, and complaint handling. The guidance provided is based on the latest scientific and technical knowledge and considers the evolving regulatory landscape and the challenges faced by the industry.

Download or read book The Qualified Person written by and published by . This book was released on 2007 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry written by Stephen Robert Goldman and published by 1st Book Library. This book was released on 2003 with total page 480 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook details methods for sustainable compliance with GxPs and 21 CFR Part 11 validation requirements regarding computerized systems in the pharmaceutical, biotechnology, and medical device industry. The handbook follows FDA guidelines and best industry practices in defining roles, responsib

Download or read book Good Quality Practice GQP in Pharmaceutical Manufacturing A Handbook written by Jordi Botet and published by Bentham Science Publishers. This book was released on 2015-09-28 with total page 504 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical manufacturing can be viewed as a supply chain which spans from the production and purchase of the starting and packaging materials through the manufacture of dosage forms until the safe reception of the finished product by the patient. The entire chain comprises of several processes: auditing, materials purchase (procurement), production, storage, distribution, quality control, and quality assurance. The quality standard for pharmaceutical production is ‘current good manufacturing practice (CGMP)’‘, which is applied within the frame of a pharmaceutical quality system (PQS). This implementation, however, requires a scientific approach and has to take into account several elements such as risk assessment, life cycle, patient protection, among other factors. Hence, pharmaceutical manufacturing is a complex subject in terms of regulation, given the technical and managerial requirements. This comprehensive handbook describes CGMP for new professionals who want to understand and apply the elements which build up pharmaceutical quality assurance. The book gives details about basic quality control requirements (such as risk management, quality hazards and management systems, documentation, clean environments, personnel training) and gives guidelines on regulatory aspects. This is an ideal handbook for undergraduates studying pharmaceutical or industrial manufacturing and supply chains as well for entrepreneurs and quality control professionals seeking to learn about CGMP standards and implementing quality assurance systems in the pharmaceutical sector.