Equipment Qualification In The Pharmaceutical Industry

Equipment Qualification in the Pharmaceutical Industry

• Author : Steven Ostrove
• Publisher : Academic Press
• Release Date : 2019-06-13
• Genre: Business & Economics
• Pages : 234
• ISBN 10 : 9780128175699

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

• Author : Phil Cloud
• Publisher : CRC Press
• Release Date : 1998-08-31
• Genre: Medical
• Pages : 456
• ISBN 10 : 1574910795

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.

Facility Validation

• Author : Graham C. Wrigley
• Publisher : CRC Press
• Release Date : 2004-03-29
• Genre: Medical
• Pages : 160
• ISBN 10 : 9781420025798

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.

Commissioning Qualification and Validation

• Author : Priscilla Browne
• Publisher : Createspace Independent Publishing Platform
• Release Date : 2017-06
• Genre: Uncategoriezed
• Pages : 200
• ISBN 10 : 1547091258

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 Equipment Validation

• Author : Phillip A. Cloud
• Publisher : Unknown
• Release Date : 1998
• Genre: MEDICAL
• Pages : 443
• ISBN 10 : 0367802996

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.

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing

• Author : Hamid Mollah
• Publisher : John Wiley & Sons
• Release Date : 2013-03-18
• Genre: Science
• Pages : 432
• ISBN 10 : 9780470552346

Sets forth tested and proven risk management practices in drug manufacturing Risk management is essential for safe and efficient pharmaceutical and biopharmaceutical manufacturing, control, and distribution. With this book as their guide, readers involved in all facets of drug manufacturing have a single, expertly written, and organized resource to guide them through all facets of risk management and analysis. It sets forth a solid foundation in risk management concepts and then explains how these concepts are applied to drug manufacturing. Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing features contributions from leading international experts in risk management and drug manufacturing. These contributions reflect the latest research, practices, and industry standards as well as the authors' firsthand experience. Readers can turn to the book for: Basic foundation of risk management principles, practices, and applications Tested and proven tools and methods for managing risk in pharmaceutical and biopharmaceutical product manufacturing processes Recent FDA guidelines, EU regulations, and international standards governing the application of risk management to drug manufacturing Case studies and detailed examples demonstrating the use and results of applying risk management principles to drug product manufacturing Bibliography and extensive references leading to the literature and helpful resources in the field With its unique focus on the application of risk management to biopharmaceutical and pharmaceutical manufacturing, this book is an essential resource for pharmaceutical and process engineers as well as safety and compliance professionals involved in drug manufacturing.

How to Validate a Pharmaceutical Process

• Author : Steven Ostrove
• Publisher : Academic Press
• Release Date : 2016-06-07
• Genre: Medical
• Pages : 218
• ISBN 10 : 9780128096536

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

Pharmaceutical Microbiological Quality Assurance and Control

• Author : David Roesti
• Publisher : John Wiley & Sons
• Release Date : 2020-01-02
• Genre: Technology & Engineering
• Pages : 594
• ISBN 10 : 9781119356073

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

Good Manufacturing Practices GMP Modules for Pharmaceutical Products

• Author : Chandrasekhar Panda
• Publisher : Pencil
• Release Date : 2021-06-24
• Genre: Social Science
• Pages : 75
• ISBN 10 : 9789354583049

This Book contains 11 Modules of Good Manufacturing Practices (GMP) for Pharmaceutical Products which will be very useful to the persons working in Pharmaceutical Industry and this can be used as a cGMP Training modules in Pharmaceutical Companies which is a basic training requirement for every employee. The Modules are Module-1 Plant Premises Module-2 Plant Equipment's Module-3 Plant Production Module-4 Plant Personnel Module-5 Plant Training, Documentation and Personnel Hygiene Module-6 Plant Quality Control Module-7 Qualification and Validation Module-8 Pharmaceutical QMS Module-9 Plant Self-Inspection and Audit Module-10 Plant Complaints and Product recall Module-11 Plant Contract Manufacturing and Contract Analysis

Current Good Manufacturing Practices cGMP for Pharmaceutical Products

• Author : Chandrasekhar Panda
• Publisher : Perfect Writer
• Release Date : 2023-06-03
• Genre: Education
• Pages : 172
• ISBN 10 : 9789395568456

This Book contains 12 modules of Current Good Manufacturing Practices (cGMP) for pharmaceutical products which will be very much useful to the persons working or interested to work in pharmaceutical industry and it is also useful for Pharmacy students. GMP is as Mandatory training requirement for every employee working in Pharmaceutical industry and this Book can be used as Training purpose in Pharmaceutical Industry. The Modules are Pharmaceutical Plant Premises Requirement, Pharmaceutical Plant Production, Pharmaceutical Plant Personnel, Pharmaceutical Plant Training, Documentation and Personnel Hygiene, Pharmaceutical Plant Quality Control, Pharmaceutical Plant Quality Assurance, Qualification and Validation Requirements, Pharmaceutical Quality Management system (QMS), Self-Inspection, Quality audits and Suppliers’ Audit, Pharmaceutical Plant Complaints and Product Recall and Pharmaceutical Plant Contract Manufacturing and Contract Analysis.

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
• Genre: Pharmaceutical industry
• Pages : 51
• ISBN 10 : OCLC:845046920

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.

Pharmaceutical Process Validation

• Author : Bernard T. Loftus
• Publisher : Marcel Dekker
• Release Date : 1984
• Genre: Drugs
• Pages : 322
• ISBN 10 : UOM:39015006032687

Pharmaceutical Industry Documents

• Author : Chandrasekhar Panda
• Publisher : Pencil
• Release Date : 2021-04-20
• Genre: Juvenile Nonfiction
• Pages : 30
• ISBN 10 : 9789354385391

About the book: This PDF contains 90 numbers pharmaceutical Industry Quality Assurance Questions and Answers which will become useful to freshers as well as 1 to 3 years of experience candidate to gain knowledge. About the author: The author of Pharmaceutical Industry Documents is Chandrasekhar panda who is having more than 13 years of Experience in Pharmaceutical Quality Assurance department and he has worked in various Pharma companies like Cipla, USV & Aurobindo Pharma Limited. The author is also having a Pharmaceutical Blog named pharmaceuticalupdates.com and written various articles or topics regarding Pharmaceutical industry.

Good Design Practices for GMP Pharmaceutical Facilities

• Author : Terry Jacobs
• Publisher : CRC Press
• Release Date : 2016-08-19
• Genre: Medical
• Pages : 535
• ISBN 10 : 9781482258912

This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.

21 CFR Part 11

• Author : Orlando López
• Publisher : CRC Press
• Release Date : 2004-01-15
• Genre: Medical
• Pages : 243
• ISBN 10 : 9781135488758

Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places