| Author | : Steven Ostrove |
| Publisher | : Academic Press |
| Release Date | : 2019-06-13 |
| ISBN 10 | : 0128175699 |
| Pages | : 234 pages |
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 | : Phillip A. Cloud |
| Publisher | : N.A |
| Release Date | : 1998 |
| ISBN 10 | : 9780367802998 |
| Pages | : 443 pages |
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.
| Author | : P. J. Cullen,Rodolfo J. Romañach,Nicolas Abatzoglou,Chris D. Rielly |
| Publisher | : John Wiley & Sons |
| Release Date | : 2015-05-11 |
| ISBN 10 | : 1118682807 |
| Pages | : 512 pages |
Written in four parts, this book provides a dedicated and in-depth reference for blending within the pharmaceutical manufacturing industry. It links the science of blending with regulatory requirements associated with pharmaceutical manufacture. The contributors are a combination of leading academic and industrial experts, who provide an informed and industrially relevant perspective of the topic. This is an essential book for the pharmaceutical manufacturing industry, and related academic researchers in pharmaceutical science and chemical and mechanical engineering.
| Author | : James P. Agalloco,Frederick J. Carleton |
| Publisher | : CRC Press |
| Release Date | : 2007-09-25 |
| ISBN 10 | : 9781420019797 |
| Pages | : 760 pages |
Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va
| Author | : Behnam Davani |
| Publisher | : John Wiley & Sons |
| Release Date | : 2017-08-01 |
| ISBN 10 | : 1119425018 |
| Pages | : 256 pages |
A comprehensive introduction for scientists engaged in new drug development, analysis, and approvals Each year the pharmaceutical industry worldwide recruits thousands of recent science graduates—especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors—into its ranks. However, because of their limited background in pharmaceutical analysis most of those new recruits find making the transition from academia to industry very difficult. Designed to assist both recent graduates, as well as experienced chemists or scientists with limited regulatory, compendial or pharmaceutical analysis background, make that transition, Pharmaceutical Analysis for Small Molecules is a concise, yet comprehensive introduction to the drug development process and analysis of chemically synthesized, small molecule drugs. It features contributions by distinguished experts in the field, including editor and author, Dr. Behnam Davani, an analytical chemist with decades of technical management and teaching experience in compendial, regulatory, and industry. This book provides an introduction to pharmaceutical analysis for small molecules (non-biologics) using commonly used techniques for drug characterization and performance tests. The driving force for industry to perform pharmaceutical analyses is submission of such data and supporting documents to regulatory bodies for drug approval in order to market their products. In addition, related required supporting studies including good laboratory/documentation practices including analytical instrument qualification are highlighted in this book. Topics covered include: Drug Approval Process and Regulatory Requirements (private standards) Pharmacopeias and Compendial Approval Process (public standards) Common methods in pharmaceutical analysis (typically compendial) Common Calculations for assays and impurities and other specific tests Analytical Method Validation, Verification, Transfer Specifications including how to handle out of specification (OOS) and out of trend (OOT) Impurities including organic, inorganic, residual solvents and elemental impurities Good Documentation Practices for regulatory environment Management of Analytical Laboratories Analytical Instrument Qualifications including IQ, OQ, PQ and VQ Due to global nature of pharmaceutical industry, other topics on both regulatory (ICH) and Compendial harmonization are also highlighted. Pharmaceutical Analysis for Small Molecules is a valuable working resource for scientists directly or indirectly involved with the drug development process, including analytical chemists, pharmaceutical scientists, pharmacists, and quality control/quality assurance professionals. It also is an excellent text/reference for graduate students in analytical chemistry, pharmacy, pharmaceutical and regulatory sciences.
| Author | : David Roesti,Marcel Goverde |
| Publisher | : John Wiley & Sons |
| Release Date | : 2020-01-02 |
| ISBN 10 | : 1119356075 |
| Pages | : 592 pages |
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
| Author | : Robert A. Nash,Alfred H. Wachter |
| Publisher | : CRC Press |
| Release Date | : 2003-03-27 |
| ISBN 10 | : 9780824708382 |
| Pages | : 776 pages |
The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.
| Author | : Phil Cloud |
| Publisher | : CRC Press |
| Release Date | : 1998-08-31 |
| ISBN 10 | : 9781574910797 |
| Pages | : 456 pages |
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.
| Author | : Steven Ostrove |
| Publisher | : Academic Press |
| Release Date | : 2016-06-07 |
| ISBN 10 | : 0128096535 |
| Pages | : 218 pages |
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
| Author | : Syed Imtiaz Haider |
| Publisher | : CRC Press |
| Release Date | : 2010-05-24 |
| ISBN 10 | : 1439826617 |
| Pages | : 608 pages |
During the past decades, enormous progress and enhancement of pharmaceutical manufacturing equipment and its use have been made. And while there are support documents, books, articles, and online resources available on the principles of cleaning and associated processing techniques, none of them provides a single database with convenient, ready-to-
| Author | : Priscilla Browne |
| Publisher | : Createspace Independent Publishing Platform |
| Release Date | : 2017-06 |
| ISBN 10 | : 9781547091256 |
| Pages | : 200 pages |
Commissioning, Qualification and Validation (CQV) are requirements of modern facilities within the Life Science industry. Be it a Medical Device Manufacturing, pharmaceuticals or bio-pharmaceuticals, each present challenges in how new facilities, equipment, utilities and processes are introduced. Providing a defined approach to CQV aligns activities to ensure success and the timely completion. This book covers the core elements of CQV including the key steps, terminology and how an integrated approach to CQV can be achieved. Chapter 1-Introduction to Commissioning & Qualification (C&Q) Chapter 2-Facilities Chapter 3-Introduction to Validation Chapter 4-Design Requirement Chapter 5-Risk Management Chapter 6-Validation Planning Chapter 7-Clean Utilities Chapter 8-Equipment Validation Chapter 9-Process Validation Chapter 10-Test Method Validation Chapter 11-Supplier Validation Chapter 12-Summary of Good Manufacturing Practices (GMP)
| Author | : Thomas Jacobsen,Albert Wertheimer |
| Publisher | : Jones & Bartlett Learning |
| Release Date | : 2010-10-25 |
| ISBN 10 | : 9780763766368 |
| Pages | : 317 pages |
With its expansion into the global marketplace, the pharmaceutical industry of today is uniquely positioned to improve the global health standards of society by saving lives and improving the quality of lives around the world. Modern Pharmaceutical Industry: A Primer comprehensively explains the broad range of divisions in this complex industry. Experts actively involved in each division discuss their own contribution to a pharmaceutical company's work and success. Divisions include regulatory affairs, research and development, intellectual property, pricing, marketing, generics, OTC, and more
| Author | : Mr. Manohar A. Potdar |
| Publisher | : Pragati Books Pvt. Ltd. |
| Release Date | : 2006 |
| ISBN 10 | : 9788185790596 |
| Pages | : 420 pages |
| Author | : Syed Imtiaz Haider |
| Publisher | : CRC Press |
| Release Date | : 2006-05-30 |
| ISBN 10 | : 9781420009415 |
| Pages | : 1144 pages |
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
| Author | : Hamid Mollah,Mike Long,Harold Baseman |
| Publisher | : John Wiley & Sons |
| Release Date | : 2013-03-18 |
| ISBN 10 | : 0470552344 |
| Pages | : 393 pages |
This book contains both the theory and practice of risk management (RM) and provides the background, tools, and application of risk in pharmaceutical and biologics manufacturing and operations. It includes case studies and specific examples of use of RM for biological and pharmaceutical product manufacture. The book also includes useful references and a bibliography for the reader who wishes to gain additional knowledge in the subject. It aids in assisting both industry and regulatory agencies to implement compliant and effective risk management approaches, and includes case studies to help with understanding.
| Author | : Satinder Ahuja,Henrik Rasmussen |
| Publisher | : Elsevier |
| Release Date | : 2011-09-21 |
| ISBN 10 | : 0080554199 |
| Pages | : 532 pages |
High pressure, or high performance, liquid chromatography (HPLC) is the method of choice for checking purity of new drug candidates, monitoring changes during scale up or revision of synthetic procedures, evaluating new formulations, and running control/assurance of the final drug product. HPLC Method Development for Pharmaceuticals provides an extensive overview of modern HPLC method development that addresses these unique concerns. Includes a review and update of the current state of the art and science of HPLC, including theory, modes of HPLC, column chemistry, retention mechanisms, chiral separations, modern instrumentation (including ultrahigh-pressure systems), and sample preparation. Emphasis has been placed on implementation in a pharmaceutical setting and on providing a practical perspective. HPLC Method Development for Pharmaceuticals is intended to be particularly useful for both novice and experienced HPLC method development chemists in the pharmaceutical industry and for managers who are seeking to update their knowledge. Covers the requirements for HPLC in a pharmaceutical setting including strategies for software and hardware validation to allow for use in a regulated laboratory Provides an overview of the pharmaceutical development process (clinical phases, chemical and pharmaceutical development activities) Discusses how HPLC is used in each phase of pharmaceutical development and how methods are developed to support activities in each phase
| Author | : Shayne Cox Gad |
| Publisher | : John Wiley & Sons |
| Release Date | : 2008-04-04 |
| ISBN 10 | : 9780470259825 |
| Pages | : 832 pages |
With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.
| Author | : Dennis Jenke |
| Publisher | : John Wiley & Sons |
| Release Date | : 2013-02-26 |
| ISBN 10 | : 1118679474 |
| Pages | : 400 pages |
Compatibility of Pharmaceutical Products and Contact Materials Dennis Jenke Important safety aspects of compatibility for therapeuticproducts and their manufacturing systems, delivery devices, andcontainers Compatibility of Pharmaceutical Products and ContactMaterials helps pharmaceutical, toxicology, analytical, andregulatory affairs professionals assess the safety of leachable andextractable chemicals associated with drug product packaging,manufacturing systems, and devices. The most comprehensive resourceavailable, its coverage includes the strategies, tactics, andregulatory requirements for performing safety assessments, alongwith the means for interpreting results. Structured around a logical framework for an extractables andleachables safety assessment and closely linked to thepharmaceutical product development process, Compatibility ofPharmaceutical Products and Contact Materials directlyaddresses the fundamental questions of "what activities need to beperformed to completely, efficiently, and effectively address theissue of product safety from an extractables and leachablesperspective?" and "when do the various required activities need tobe performed?" Specifically, the chapters describe: Pertinent regulations and practical ways to meetguidelines Coordinating manufacturing, storage, and delivery systemsdevelopment and qualification with therapeutic productdevelopment Materials characterization and the materials screeningprocess Component and/or system qualification (illustrated by severalcase studies) Performing validation/migration studies and interpreting andreporting the results Creating a product registration dossier and putting it throughregulatory review Product maintenance (Change Control) from an extractables andleachables perspective Likely future developments in extractables and leachablesassessment Additionally, the book's appendix provides a database, includingCAS registry numbers, chemical formulas and molecular weights ofextractable/leachable substances that have been reported in thechemical literature. Detailing the interconnected roles played by analyticalchemistry, biological science, toxicology, and regulatory science,Compatibility of Pharmaceutical Products and ContactMaterials supplies a much-needed, comprehensive resource to allthose in pharmaceutical product or medical device development.
| Author | : Bernard T. Loftus,Robert A. Nash |
| Publisher | : Marcel Dekker Incorporated |
| Release Date | : 1984 |
| ISBN 10 | : |
| Pages | : 286 pages |
| Author | : Destin a LeBlanc |
| Publisher | : CRC Press |
| Release Date | : 2019-08-30 |
| ISBN 10 | : 9780367398873 |
| Pages | : 304 pages |
Written by an expert for those who must design validatable cleaning processes and then validate those processes, this book discusses interdependent topics from various technical areas and disciplines. It shows how each piece of the cleaning process fits into the validation program, making it more defensible in both internal quality audits and external regulatory audits. Designed for use in the overall validation program, the book demonstrates how to build a comprehensive program, and includes discussion and examples of cleaning systems, regulatory requirements, and special topics and issues. It provides an FDA cleaning validation guidance document and a comprehensive glossary.