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: 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 Blending and Mixing

Pharmaceutical Blending and Mixing
Author: P. J. Cullen,Rodolfo J. Romañach,Nicolas Abatzoglou,Chris D. Rielly
Publsiher: John Wiley & Sons
Total Pages: 512
Release: 2015-05-11
ISBN 10: 1118682807
ISBN 13: 9781118682807
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.

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: 9781420019797
ISBN 13: 1420019791
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 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 Microbiological Quality Assurance and Control

Pharmaceutical Microbiological Quality Assurance and Control
Author: David Roesti,Marcel Goverde
Publsiher: John Wiley & Sons
Total Pages: 592
Release: 2020-01-02
ISBN 10: 1119356075
ISBN 13: 9781119356073
Language: EN, FR, DE, ES & NL

Pharmaceutical Microbiological Quality Assurance and Control Book Review:

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

Cleaning Validation Manual

Cleaning Validation Manual
Author: Syed Imtiaz Haider
Publsiher: CRC Press
Total Pages: 608
Release: 2010-05-24
ISBN 10: 1439826617
ISBN 13: 9781439826614
Language: EN, FR, DE, ES & NL

Cleaning Validation Manual Book Review:

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-

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)

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.

Modern Pharmaceutical Industry

Modern Pharmaceutical Industry
Author: Thomas Jacobsen,Albert Wertheimer
Publsiher: Jones & Bartlett Learning
Total Pages: 317
Release: 2010-10-25
ISBN 10: 9780763766368
ISBN 13: 0763766364
Language: EN, FR, DE, ES & NL

Modern Pharmaceutical Industry Book Review:

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

Pharmaceutical Quality Assurance

Pharmaceutical Quality Assurance
Author: Mr. Manohar A. Potdar
Publsiher: Pragati Books Pvt. Ltd.
Total Pages: 420
Release: 2006
ISBN 10: 9788185790596
ISBN 13: 8185790590
Language: EN, FR, DE, ES & NL

Pharmaceutical Quality Assurance 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: 9781420009415
ISBN 13: 1420009419
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

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

HPLC Method Development for Pharmaceuticals

HPLC Method Development for Pharmaceuticals
Author: Satinder Ahuja,Henrik Rasmussen
Publsiher: Elsevier
Total Pages: 532
Release: 2011-09-21
ISBN 10: 0080554199
ISBN 13: 9780080554198
Language: EN, FR, DE, ES & NL

HPLC Method Development for Pharmaceuticals Book Review:

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

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.

Manufacturing of Pharmaceutical Proteins

Manufacturing of Pharmaceutical Proteins
Author: Stefan Behme
Publsiher: John Wiley & Sons
Total Pages: 456
Release: 2015-05-06
ISBN 10: 3527337660
ISBN 13: 9783527337668
Language: EN, FR, DE, ES & NL

Manufacturing of Pharmaceutical Proteins Book Review:

Structured like a textbook, the second edition of this reference covers all aspects of biopharmaceutical manufacturing, including legal and regulatory issues, production facility design, and quality assurance, with a focus on supply chain management and regulations in emerging markets and cost control. The author has longstanding industrial expertise in biopharmaceutical production and years of experience teaching at universities. As such, this practical book is ideal for use in academia as well as for internal training within companies.

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.

Laboratory Control System Operations in a GMP Environment

Laboratory Control System Operations in a GMP Environment
Author: David M. Bliesner
Publsiher: John Wiley & Sons
Total Pages: 320
Release: 2020-04-21
ISBN 10: 1119529271
ISBN 13: 9781119529279
Language: EN, FR, DE, ES & NL

Laboratory Control System Operations in a GMP Environment Book Review:

Develop an understanding of FDA and global regulatory agency requirements for Laboratory Control System (LCS) operations In Laboratory Control System Operations in a GMP Environment, readers are given the guidance they need to implement a CGMP compliant Laboratory Control System (LCS) that fits within Global Regulatory guidelines. Using the Quality Systems Approach, regulatory agencies like the FDA and the European Medicine Agency have developed a scheme of systems for auditing pharmaceutical manufacturing facilities which includes evaluating the LCS. In this guide, readers learn the fundamental rules for operating a CGMP compliant Laboratory Control System. Designed to help leaders meet regulatory standards and operate more efficiently, the text includes chapters that cover Laboratory Equipment Qualification and Calibration, Laboratory Facilities, Method Validation and Method Transfer, Laboratory Computer Systems, Laboratory Investigations as well as Data Governance and Data Integrity. The text also includes chapters related to Laboratory Managerial and Administrative Systems, Laboratory Documentation Practices and Standard Operating Procedures and General Laboratory Compliance Practices. Additionally, a chapter outlining Stability Program operations is included in the text. In addition to these topics, it includes LCS information and tools such as: ● End of chapter templates, checklists, and LCS guidance to help you follow the required standards ● Electronic versions of each tool so users can use them outside of the text ● An In-depth understanding of what is required by the FDA and other globally significant regulatory authorities for GMP compliant systems For quality assurance professionals working within the pharmaceutical or biopharma industries, this text provides the insight and tools necessary to implement government-defined regulations.

Pharmaceutical Process Validation

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

Pharmaceutical Process Validation Book Review:

Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry

Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry
Author: Stephen Robert Goldman
Publsiher: AuthorHouse
Total Pages: 472
Release: 2003
ISBN 10:
ISBN 13: UOM:39015058098412
Language: EN, FR, DE, ES & NL

Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry Book Review:

The Curse is a tale of horror and suspense. It tells the story of a group of common people fleeing from their daunting past, and their struggle for survival. It shows how man's evil transgression and guilty conscience will literally follow him to his death, and perhaps even cause it. It also tells of how one man's fault could not only lead to his suffering, but also to those he holds dear. The tale begins when a group of six daring, young teenage boys plan an upcoming Halloween prank. The mastermind of the six, Jack Boomer, decides to try something different and more dangerous than the previous years. He plans to blow up the shack with a pile of firecrackers. Four of his cronies immediately agree with his plan; however, Ted Dot, the pessimistic, redheaded teenager, is reluctant. He tries to explain to them the consequences of being caught. The other five are not dissuaded from the idea, and they somehow talk Ted into going along with them. Once all six confirm their new idea, they gather their materials. On Halloween night, they set out to execute their plan. Everything works out perfectly for them, and the shack soon erupts into a blazing fury. Their celebration is short-lived, though. From out of the forest appears a mysterious old woman. Her ethnicity is unknown, her origin is unknown, why she is bald, wears a polka-dotted skullcap, wraps her feet in construction paper for shoes, and wears a mud-stained, dark brown dress is all unknown, and it remains unknown throughout the story. The entire time she is simply referred to as the "old woman." In her hand she carries a long, gnarled staff the most significant figure in the entire piece. This stranger claims that the destroyed shack was her home, and she doesn't give the six teenagers a chance to explain. She unleashes her fury and invokes a horrible curse upon them. From then on, it is the ultimate survival story for the six boys. Not only do they suffer the consequences, but also their family members and other best friends are part of the ordeal. And, the "old woman" claims, the terrible conflict does not cease until all six of them have been wiped out.