Validated Cleaning Technologies For Pharmaceutical Manufacturing
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| Author | : Destin a LeBlanc |
| Publisher | : CRC Press |
| Total Pages | : 304 |
| Release | : 2019-08-30 |
| Genre | : |
| ISBN | : 9780367398873 |
Written by an expert for those who must design validatable cleaning processes and then validate those processes, this book discusses interdependent topics from various technical areas and disciplines. It shows how each piece of the cleaning process fits into the validation program, making it more defensible in both internal quality audits and external regulatory audits. Designed for use in the overall validation program, the book demonstrates how to build a comprehensive program, and includes discussion and examples of cleaning systems, regulatory requirements, and special topics and issues. It provides an FDA cleaning validation guidance document and a comprehensive glossary.
| Author | : Destin A. LeBlanc |
| Publisher | : CRC Press |
| Total Pages | : 216 |
| Release | : 2022-12-23 |
| Genre | : Medical |
| ISBN | : 1000835596 |
Pharmaceutical manufacturers and upper management are encouraged to meet the challenges of the science-based and risk-based approaches to cleaning validation. Using some of the principles and practices in this volume will help in designing a more effective and efficient cleaning validation program. Features • Timely coverage of cleaning validation for the pharmaceutical industry, a dynamic area in terms of health-based limits. • The author encourages pharmaceutical manufacturers, and particularly upper management, to meet the challenges of the science-based and riskbased approaches to cleaning validation. • Draws on the author’s vast experience in the field of cleaning validation and hazardous materials. • Discusses EMA vs. ISPE on Cleaning Limits and revised Risk-MaPP for highly hazardous products in shared facilities. • A diverse list of topics from protocol limits for yeasts and molds to cleaning validation for homeopathic drug products.
| Author | : Syed Imtiaz Haider |
| Publisher | : CRC Press |
| Total Pages | : 608 |
| Release | : 2010-05-24 |
| Genre | : Medical |
| ISBN | : 1439826617 |
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-
| Author | : Destin A. LeBlanc |
| Publisher | : CRC Press |
| Total Pages | : 0 |
| Release | : 2023 |
| Genre | : Medical |
| ISBN | : 9781003366003 |
"Pharmaceutical manufacturers and upper management are encouraged to meet the challenges of the science-based and risk-based approaches to cleaning validation. Using some of the principles and practices in this volume will help in designing a more effective and efficient cleaning validation program. Timely coverage of cleaning validation for the pharmaceutical industry is a dynamic area in terms of health-based limits. Author encourages pharmaceutical manufacturers, and particularly upper management, to meet the challenges of the science-based and risk-based approaches to cleaning validation. Draws on the author's vast experience in the field of cleaning validation and hazardous materials. Discusses EMA vs. ISPE on Cleaning Limits and revised Risk-MaPP for highly hazardous products in shared facilities. Diverse list of topics from protocol limits for yeasts and molds to cleaning validation for homeopathic drug products"--
| Author | : Priscilla Browne |
| Publisher | : |
| Total Pages | : 120 |
| Release | : 2017-08-14 |
| Genre | : |
| ISBN | : 9781974570263 |
This paperback book (Reference Edition) provides an introduction to Cleaning Verification and Validation for pharmaceutical and biological equipment and facilities. It provides a practical framework for the design and execution of cleaning validation. Cleaning Validation is a regulatory requirement as per GMP. There are many organisations and bodies which provide guidance of implementing a Cleaning Program such as PIC/s ICH, PDA reports, EU GMP V4 to name a few. The key elements to achieving a successful cleaning validation include (1) understanding the sources of residues (soils, excipients, actives, microbes etc) (2) developing a cleaning procedure (3) developing a test method (4) validating the cleaning procedure in respect of the products and equipment to be used in manufacturing. Summary of title index Introduction,What is Cleaning, Why Clean,Verification and Validation Definitions, Regulatory Requirements FDA, EU GMP. ICH Q7, Validation Standards Stages of Validation, Stage 1 Process Design Stage 2 Process Qualification, Stage 3 Continued Process Verification, Validation General Principles and Practices Cleaning Validation Prerequisites to Cleaning Validation Execution Validation Report Clean In Place (CIP) Visibly Clean Soils and their behaviour Detergents Validation Strategies Summary How are Acceptance levels defined? Historical Context of Limits Uses of the term limit PDA Technical Report No. 29 Calculation of MACO MACO for each piece of equipment Cleaning Validation Protocol PIC/S Guidance on Limits Test Methods ICH Q7 Validation of Analytical Methods Definitions Cleaning Process Design Equipment Considerations Cleaning Agent Approval Critical Cleaning Parameters Cleaning Pipes Dead Legs Connections and Tie-ins Valves Materials of Construction Pressure Testing Sampling Direct Sampling Rinse Sampling Sources of Contaminants Utilities Introduction Key Definitions Compressed Air Water Systems Clean Steam Useful References Appendix Precision Cleaning (Medical Devices)Page Count 119, Reference Edition, 8" X 10" Paperback
| Author | : James P. Agalloco |
| Publisher | : CRC Press |
| Total Pages | : 762 |
| Release | : 2007-09-25 |
| Genre | : Medical |
| ISBN | : 1420019791 |
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
| Author | : Steven Ostrove |
| Publisher | : Academic Press |
| Total Pages | : 234 |
| Release | : 2019-06-13 |
| Genre | : Business & Economics |
| ISBN | : 0128175699 |
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
| Author | : James Philip Woodin |
| Publisher | : |
| Total Pages | : 252 |
| Release | : 2000 |
| Genre | : |
| ISBN | : |
| Author | : Bill Hall |
| Publisher | : |
| Total Pages | : 346 |
| Release | : 1997-09 |
| Genre | : |
| ISBN | : 9781566765633 |
| Author | : Chung Chow Chan |
| Publisher | : John Wiley & Sons |
| Total Pages | : 363 |
| Release | : 2011-03-01 |
| Genre | : Science |
| ISBN | : 1118060318 |
Practical approaches to ensure that analytical methods and instruments meet GMP standards and requirements Complementing the authors' first book, Analytical Method Validation and Instrument Performance Verification, this new volume provides coverage of more advanced topics, focusing on additional and supplemental methods, instruments, and electronic systems that are used in pharmaceutical, biopharmaceutical, and clinical testing. Readers will gain new and valuable insights that enable them to avoid common pitfalls in order to seamlessly conduct analytical method validation as well as instrument operation qualification and performance verification. Part 1, Method Validation, begins with an overview of the book's risk-based approach to phase appropriate validation and instrument qualification; it then focuses on the strategies and requirements for early phase drug development, including validation of specific techniques and functions such as process analytical technology, cleaning validation, and validation of laboratory information management systems Part 2, Instrument Performance Verification, explores the underlying principles and techniques for verifying instrument performance—coverage includes analytical instruments that are increasingly important to the pharmaceutical industry, such as NIR spectrometers and particle size analyzers—and offers readers a variety of alternative approaches for the successful verification of instrument performance based on the needs of their labs At the end of each chapter, the authors examine important practical problems and share their solutions. All the methods covered in this book follow Good Analytical Practices (GAP) to ensure that reliable data are generated in compliance with current Good Manufacturing Practices (cGMP). Analysts, scientists, engineers, technologists, and technical managers should turn to this book to ensure that analytical methods and instruments are accurate and meet GMP standards and requirements.
