Equipment Qualification in the Pharmaceutical Industry

Equipment Qualification in the Pharmaceutical Industry
Author: Steven Ostrove
Publsiher: Academic Press
Total Pages: 234
Release: 2019-06-13
ISBN 10: 0128175699
ISBN 13: 9780128175699
Language: EN, FR, DE, ES & NL

Equipment Qualification in the Pharmaceutical Industry Book Review:

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

Pharmaceutical Equipment Validation

Pharmaceutical Equipment Validation
Author: Phil Cloud
Publsiher: CRC Press
Total Pages: 456
Release: 1998-08-31
ISBN 10: 9781574910797
ISBN 13: 1574910795
Language: EN, FR, DE, ES & NL

Pharmaceutical Equipment Validation Book Review:

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.

Pharmaceutical Blending and Mixing

Pharmaceutical Blending and Mixing
Author: P. J. Cullen,Chris D. Rielly
Publsiher: John Wiley & Sons
Total Pages: 508
Release: 2015-07-20
ISBN 10: 0470710551
ISBN 13: 9780470710555
Language: EN, FR, DE, ES & NL

Pharmaceutical Blending and Mixing Book Review:

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.

Equipment Qualification of Ion Mobility Spectrometry and Method Development and Validation for Pharmaceutical Equipment Cleaning Validation

Equipment Qualification of Ion Mobility Spectrometry and Method Development and Validation for Pharmaceutical Equipment Cleaning Validation
Author: Amy Lee Heiser
Publsiher: Unknown
Total Pages: 51
Release: 2012
ISBN 10: 1928374650XXX
ISBN 13: OCLC:845046920
Language: EN, FR, DE, ES & NL

Equipment Qualification of Ion Mobility Spectrometry and Method Development and Validation for Pharmaceutical Equipment Cleaning Validation Book Review:

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.

How to Validate a Pharmaceutical Process

How to Validate a Pharmaceutical Process
Author: Steven Ostrove
Publsiher: Academic Press
Total Pages: 218
Release: 2016-06-07
ISBN 10: 0128096535
ISBN 13: 9780128096536
Language: EN, FR, DE, ES & NL

How to Validate a Pharmaceutical Process Book Review:

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

Commissioning Qualification and Validation

Commissioning  Qualification and Validation
Author: Priscilla Browne
Publsiher: Createspace Independent Publishing Platform
Total Pages: 200
Release: 2017-06
ISBN 10: 9781547091256
ISBN 13: 1547091258
Language: EN, FR, DE, ES & NL

Commissioning Qualification and Validation Book Review:

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)

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing
Author: Hamid Mollah,Mike Long,Harold Baseman
Publsiher: John Wiley & Sons
Total Pages: 393
Release: 2013-03-18
ISBN 10: 0470552344
ISBN 13: 9780470552346
Language: EN, FR, DE, ES & NL

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing Book Review:

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.

Pharmaceutical Equipment Validation

Pharmaceutical Equipment Validation
Author: Phillip A. Cloud
Publsiher: Unknown
Total Pages: 443
Release: 1998
ISBN 10: 9780367802998
ISBN 13: 0367802996
Language: EN, FR, DE, ES & NL

Pharmaceutical Equipment Validation Book Review:

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.

Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation

Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation
Author: Orlando Lopez
Publsiher: Taylor & Francis
Total Pages: 326
Release: 2018-10-02
ISBN 10: 1351704346
ISBN 13: 9781351704342
Language: EN, FR, DE, ES & NL

Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation Book Review:

Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement (PICS CSV PI 011-3). It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority’s requirements. Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions. This book, which is relevant to the pharmaceutical and medical devices regulated operations, provides practical information to assist in the computer validation to production systems, while highlighting and efficiently integrating worldwide regulation into the subject. A practical approach is presented to increase efficiency and to ensure that the validation of computer systems is correctly achieved.

Validation of Pharmaceutical Processes

Validation of Pharmaceutical Processes
Author: James P. Agalloco,Frederick J. Carleton
Publsiher: CRC Press
Total Pages: 760
Release: 2007-09-25
ISBN 10: 1420019791
ISBN 13: 9781420019797
Language: EN, FR, DE, ES & NL

Validation of Pharmaceutical Processes Book Review:

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

Pharmaceutical Quality Systems

Pharmaceutical Quality Systems
Author: Oliver Schmidt
Publsiher: CRC Press
Total Pages: 392
Release: 2000-04-30
ISBN 10: 142002602X
ISBN 13: 9781420026023
Language: EN, FR, DE, ES & NL

Pharmaceutical Quality Systems Book Review:

When a pharmaceutical company decides to build a Quality System, it has to face the fact that there aren't any guideline that define exactly how such a system has to be built. With terms such as quality system, quality assurance, and quality management used interchangeably, even defining the system's objectives is a problem. This book provides a pr

Facility Validation

Facility Validation
Author: Graham C. Wrigley
Publsiher: CRC Press
Total Pages: 160
Release: 2004-03-29
ISBN 10: 1420025791
ISBN 13: 9781420025798
Language: EN, FR, DE, ES & NL

Facility Validation Book Review:

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 explores the validation issues relevant to the start-up of a new or upgraded manufacturing facility. The author describes policies, guidelines, and regulations relating to GMPs in the pharmaceutical industry and explores the relationship between these GMPs and the validation process. He outlines the theory and clarifies the philosophy and key principles of validation such as life-cycle approach and qualification practices. The book includes coverage of common pitfalls and how to avoid them, the difficulties and constraints a validation team has to manage, and the dangers of not adopting and following the recommended best practices. Facility validation has, in fact, become good business. It can be a tool for enhancing reliability, cost, and quality. This book makes the case that design, engineering, commissioning, and validation activities can be integrated and streamlined to accelerate a pharmaceutical manufacturing plant start-up effort, and demonstrates how to use best practices to achieve the results you desire in your organization.

Compatibility of Pharmaceutical Solutions and Contact Materials

Compatibility of Pharmaceutical Solutions and Contact Materials
Author: Dennis Jenke
Publsiher: John Wiley & Sons
Total Pages: 400
Release: 2013-02-26
ISBN 10: 1118679474
ISBN 13: 9781118679470
Language: EN, FR, DE, ES & NL

Compatibility of Pharmaceutical Solutions and Contact Materials Book Review:

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.

Pharmaceutical Manufacturing Handbook

Pharmaceutical Manufacturing Handbook
Author: Shayne Cox Gad
Publsiher: John Wiley & Sons
Total Pages: 832
Release: 2008-04-04
ISBN 10: 9780470259825
ISBN 13: 0470259825
Language: EN, FR, DE, ES & NL

Pharmaceutical Manufacturing Handbook Book Review:

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.

Pharmaceutical Computer Systems Validation

Pharmaceutical Computer Systems Validation
Author: Guy Wingate
Publsiher: CRC Press
Total Pages: 798
Release: 2016-04-19
ISBN 10: 1420088955
ISBN 13: 9781420088953
Language: EN, FR, DE, ES & NL

Pharmaceutical Computer Systems Validation Book Review:

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 r

Pharmaceutical Process Validation

Pharmaceutical Process Validation
Author: Robert A. Nash,Alfred H. Wachter
Publsiher: CRC Press
Total Pages: 776
Release: 2003-03-27
ISBN 10: 9780824708382
ISBN 13: 0824708385
Language: EN, FR, DE, ES & NL

Pharmaceutical Process Validation Book Review:

The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.

Analytical Method Validation and Instrument Performance Verification

Analytical Method Validation and Instrument Performance Verification
Author: Chung Chow Chan,Y. C. Lee,Herman Lam,Xue-Ming Zhang
Publsiher: John Wiley & Sons
Total Pages: 320
Release: 2004-04-23
ISBN 10: 9780471463719
ISBN 13: 047146371X
Language: EN, FR, DE, ES & NL

Analytical Method Validation and Instrument Performance Verification Book Review:

Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories.

Pharmaceutical Microbiology Manual

Pharmaceutical Microbiology Manual
Author: United States Food and Drug Administration
Publsiher: Createspace Independent Publishing Platform
Total Pages: 92
Release: 2017-09-21
ISBN 10: 9781976578670
ISBN 13: 1976578671
Language: EN, FR, DE, ES & NL

Pharmaceutical Microbiology Manual Book Review:

Manual and is a supplement to the United States Pharmacopeia (USP) for pharmaceutical microbiology testing, including antimicrobial effectiveness testing, microbial examination of non-sterile products, sterility testing, bacterial endotoxin testing, particulate matter, device bioburden and environmental monitoring testing. The goal of this manual is to provide an ORA/CDER harmonized framework on the knowledge, methods and tools needed, and to apply the appropriate scientific standards required to assess the safety and efficacy of medical products within FDA testing laboratories. The PMM has expanded to include some rapid screening techniques along with a new section that covers inspectional guidance for microbiologists that conduct team inspections. This manual was developed by members of the Pharmaceutical Microbiology Workgroup and includes individuals with specialized experience and training. The instructions in this document are guidelines for FDA analysts. When available, analysts should use procedures and worksheets that are standardized and harmonized across all ORA field labs, along with the PMM, when performing analyses related to product testing of pharmaceuticals and medical devices. When changes or deviations are necessary, documentation should be completed per the laboratory's Quality Management System. Generally, these changes should originate from situations such as new products, unusual products, or unique situations. This manual was written to reduce compendia method ambiguity and increase standardization between FDA field laboratories. By providing clearer instructions to FDA ORA labs, greater transparency can be provided to both industry and the public. However, it should be emphasized that this manual is a supplement, and does not replace any information in USP or applicable FDA official guidance references. The PMM does not relieve any person or laboratory from the responsibility of ensuring that the methods being employed from the manual are fit for use, and that all testing is validated and/or verified by the user. The PMM will continually be revised as newer products, platforms and technologies emerge or any significant scientific gaps are identified with product testing. Reference to any commercial materials, equipment, or process in the PMM does not in any way constitute approval, endorsement, or recommendation by the U.S. Food and Drug Administration.

Pharmaceutical Process Validation

Pharmaceutical Process Validation
Author: Bernard T. Loftus,Robert A. Nash
Publsiher: Marcel Dekker Incorporated
Total Pages: 286
Release: 1984
ISBN 10: 1928374650XXX
ISBN 13: UOM:39015006032687
Language: EN, FR, DE, ES & NL

Pharmaceutical Process Validation Book Review:

Validation Standard Operating Procedures

Validation Standard Operating Procedures
Author: Syed Imtiaz Haider
Publsiher: CRC Press
Total Pages: 1144
Release: 2006-05-30
ISBN 10: 1420009419
ISBN 13: 9781420009415
Language: EN, FR, DE, ES & NL

Validation Standard Operating Procedures Book Review:

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