Cleaning Validation Manual

Cleaning Validation Manual
Author :
Publisher : CRC Press
Total Pages : 610
Release :
ISBN-10 : 9781439826614
ISBN-13 : 1439826617
Rating : 4/5 (617 Downloads)

Book Synopsis Cleaning Validation Manual by : Syed Imtiaz Haider

Download or read book Cleaning Validation Manual written by Syed Imtiaz Haider and published by CRC Press. This book was released on 2010-05-24 with total page 610 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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-use training tools. Until now. Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries elucidates how to train the man power involved in development, manufacturing, auditing, and validation of bio pharmaceuticals on a pilot scale, leading to scale-up production. With over 20 easy-to-use template protocols for cleaning validation of extensively used equipments, this book provides technical solutions to assist in fulfilling the training needs of finished pharmaceutical manufacturers. Drawing on the authors’ more than two decades of experience in the pharmaceutical and biotech industries, the text offers hands-on training based on current approaches and techniques. The book does not merely provide guidelines or thought processes, rather it gives ready-to-use formulas to develop Master Plan, SOPs, and validation protocols. It includes cleaning procedures for the most commonly used equipment in various manufacturing areas and their sampling points, using a pharmaceutical manufacturing site with both sterile and non-sterile operations as the case facility. It also provides the training guidelines on downloadable resources to enable users to amend or adopt them as necessary. Grounded in practicality, the book’s applicability and accessibility set it apart. It can be used as a guide for implementing a cleaning validation program on site without the help of external consultants, making it a resource that will not be found collecting dust on a shelf, but rather, referred to again and again.


Cleaning Validation Manual Related Books

Cleaning Validation Manual
Language: en
Pages: 610
Authors: Syed Imtiaz Haider
Categories: Medical
Type: BOOK - Published: 2010-05-24 - Publisher: CRC Press

DOWNLOAD EBOOK

During the past decades, enormous progress and enhancement of pharmaceutical manufacturing equipment and its use have been made. And while there are support doc
Cleaning Validation
Language: en
Pages: 216
Authors: Destin A. LeBlanc
Categories: Medical
Type: BOOK - Published: 2022-12-23 - Publisher: CRC Press

DOWNLOAD EBOOK

Pharmaceutical manufacturers and upper management are encouraged to meet the challenges of the science-based and risk-based approaches to cleaning validation. U
Cleaning Validation
Language: en
Pages: 200
Authors: Gil Bismuth
Categories: Clean rooms
Type: BOOK - Published: 2019-09-05 - Publisher: CRC Press

DOWNLOAD EBOOK

Offering a detailed, step-by-step guide to building a compliant cleaning validation program, Cleaning Validation: A Practical Approach covers trends in control,
Guideline on General Principles of Process Validation
Language: en
Pages: 32
Authors:
Categories: Medical instruments and apparatus industry
Type: BOOK - Published: 1987 - Publisher:

DOWNLOAD EBOOK

Cleaning and Cleaning Validation
Language: en
Pages: 198
Authors: Jon Voss
Categories: Medical
Type: BOOK - Published: 2018-05-04 - Publisher: Routledge

DOWNLOAD EBOOK

This book is intended to serve as a source of practical, technicalinformation for those persons in the biotechnology industry. Casestudies and/ or actual indust