Equipment Qualification in the Pharmaceutical Industry

Written By Steven Ostrove
Equipment Qualification in the Pharmaceutical Industry
  • Publsiher : Academic Press
  • Release : 13 June 2019
  • ISBN : 0128175699
  • Pages : 234 pages
  • Rating : 4/5 from 21 reviews
GET THIS BOOKEquipment Qualification in the Pharmaceutical Industry


Read or download book entitled Equipment Qualification in the Pharmaceutical Industry written by Steven Ostrove which was release on 13 June 2019, this book published by Academic Press. Available in PDF, EPUB and Kindle Format. 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

Equipment Qualification in the Pharmaceutical Industry

Equipment Qualification in the Pharmaceutical Industry
  • Author : Steven Ostrove
  • Publisher : Academic Press
  • Release Date : 2019-06-13
  • Total pages : 234
  • ISBN : 0128175699
GET BOOK

Summary : 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 ...

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
  • Publisher : Unknown
  • Release Date : 2012
  • Total pages : 51
  • ISBN : 0128175699
GET BOOK

Summary : 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 ...

Modern Pharmaceutical Industry

Modern Pharmaceutical Industry
  • Author : Thomas Jacobsen,Albert Wertheimer
  • Publisher : Jones & Bartlett Learning
  • Release Date : 2010-10-25
  • Total pages : 317
  • ISBN : 0128175699
GET BOOK

Summary : 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 ...

Validation of Pharmaceutical Processes

Validation of Pharmaceutical Processes
  • Author : James P. Agalloco,Frederick J. Carleton
  • Publisher : CRC Press
  • Release Date : 2007-09-25
  • Total pages : 760
  • ISBN : 0128175699
GET BOOK

Summary : 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
  • Publisher : CRC Press
  • Release Date : 1998-08-31
  • Total pages : 456
  • ISBN : 0128175699
GET BOOK

Summary : 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. ...

Pharmaceutical Manufacturing Handbook

Pharmaceutical Manufacturing Handbook
  • Author : Shayne Cox Gad
  • Publisher : John Wiley & Sons
  • Release Date : 2008-04-04
  • Total pages : 832
  • ISBN : 0128175699
GET BOOK

Summary : 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 ...

Pharmaceutical Equipment Validation

Pharmaceutical Equipment Validation
  • Author : Phillip A. Cloud
  • Publisher : Unknown
  • Release Date : 1998
  • Total pages : 443
  • ISBN : 0128175699
GET BOOK

Summary : 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. ...

Facility Validation

Facility Validation
  • Author : Graham C. Wrigley
  • Publisher : CRC Press
  • Release Date : 2004-03-29
  • Total pages : 160
  • ISBN : 0128175699
GET BOOK

Summary : 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 ...

Pharmaceutical Analysis for Small Molecules

Pharmaceutical Analysis for Small Molecules
  • Author : Behnam Davani
  • Publisher : John Wiley & Sons
  • Release Date : 2017-08-14
  • Total pages : 256
  • ISBN : 0128175699
GET BOOK

Summary : 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 ...

Pharmaceutical Blending and Mixing

Pharmaceutical Blending and Mixing
  • Author : P. J. Cullen,Chris D. Rielly
  • Publisher : John Wiley & Sons
  • Release Date : 2015-07-20
  • Total pages : 508
  • ISBN : 0128175699
GET BOOK

Summary : 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 ...

Pharmaceutical Quality Systems

Pharmaceutical Quality Systems
  • Author : Oliver Schmidt
  • Publisher : CRC Press
  • Release Date : 2000-04-30
  • Total pages : 392
  • ISBN : 0128175699
GET BOOK

Summary : 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 ...

Multivariate Analysis in the Pharmaceutical Industry

Multivariate Analysis in the Pharmaceutical Industry
  • Author : Ana Patricia Ferreira,Jose C. Menezes,Mike Tobyn
  • Publisher : Academic Press
  • Release Date : 2018-04-24
  • Total pages : 464
  • ISBN : 0128175699
GET BOOK

Summary : Multivariate Analysis in the Pharmaceutical Industry provides industry practitioners with guidance on multivariate data methods and their applications over the lifecycle of a pharmaceutical product, from process development, to routine manufacturing, focusing on the challenges specific to each step. It includes an overview of regulatory guidance specific to the use ...

Pharmaceutical Microbiological Quality Assurance and Control

Pharmaceutical Microbiological Quality Assurance and Control
  • Author : David Roesti,Marcel Goverde
  • Publisher : John Wiley & Sons
  • Release Date : 2020-01-02
  • Total pages : 592
  • ISBN : 0128175699
GET BOOK

Summary : 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 ...

Chemical Engineering in the Pharmaceutical Industry

Chemical Engineering in the Pharmaceutical Industry
  • Author : David J. am Ende
  • Publisher : John Wiley & Sons
  • Release Date : 2011-03-10
  • Total pages : 904
  • ISBN : 0128175699
GET BOOK

Summary : This book deals with various unique elements in the drugdevelopment process within chemical engineering science andpharmaceutical R&D. The book is intended to be used as aprofessional reference and potentially as a text book reference inpharmaceutical engineering and pharmaceutical sciences. Many of theexperimental methods related to pharmaceutical process developmentare learned ...

Gas Chromatographic Techniques and Applications

Gas Chromatographic Techniques and Applications
  • Author : Alan John Handley,E. R. Adlard
  • Publisher : Taylor & Francis
  • Release Date : 2001
  • Total pages : 337
  • ISBN : 0128175699
GET BOOK

Summary : This volume provides an overview of the state of the art in gas chromatography with an emphasis on new technologies. The authors-all drawn from respected industrial and academic laboratories-consider developments in gas chromatographic techniques over the last decade. Application areas are addressed within individual chapters....