Book > Equipment Qualification In The Pharmaceutical Industry

Equipment Qualification in the Pharmaceutical Industry

Equipment Qualification in the Pharmaceutical Industry

Detail Book : Equipment Qualification in the Pharmaceutical Industry written by Steven Ostrove, published by Academic Press which was released on 13 June 2019. Download Equipment Qualification in the Pharmaceutical Industry Books now! Available in PDF, ePub and Kindle. 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

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Author : Steven Ostrove
Release Date : 13 June 2019
Publisher : Academic Press
Rating : 4/5 (from 21 users)
Pages : 234
ISBN : 0128175699
Format : PDF, ePUB, KF8, PDB, MOBI, Tuebl
Equipment Qualification in the Pharmaceutical Industry

Equipment Qualification in the Pharmaceutical Industry

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

GET BOOK
Pharmaceutical Equipment Validation

Pharmaceutical Equipment Validation

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.

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Pharmaceutical Blending and Mixing

Pharmaceutical Blending and Mixing

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Validation of Pharmaceutical Processes

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Pharmaceutical Equipment Validation

Pharmaceutical Equipment Validation

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.

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Pharmaceutical Microbiological Quality Assurance and Control

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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

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Pharmaceutical Process Validation

Pharmaceutical Process Validation

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

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Cleaning Validation Manual

Cleaning Validation Manual

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-

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How to Validate a Pharmaceutical Process

How to Validate a Pharmaceutical Process

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

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Pharmaceutical Quality Assurance

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Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing

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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

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Commissioning  Qualification and Validation

Commissioning Qualification and Validation

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

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Modern Pharmaceutical Industry

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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

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Compatibility of Pharmaceutical Solutions and Contact Materials

Compatibility of Pharmaceutical Solutions and Contact Materials

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,

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