Pharmaceutical Science

Validation

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The Pharmaceutical Regulatory Process

2nd Edition

Ira R. Berry, Robert P. Martin
June 07, 2019

This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by...

Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries

1st Edition

Syed Imtiaz Haider
July 31, 2018

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...

Bio-Targets and Drug Delivery Approaches

1st Edition

Sabyasachi Maiti, Kalyan Kumar Sen
October 18, 2016

The advances in drug delivery systems over recent years have resulted in a large number of novel delivery systems with the potential to revolutionize the treatment and prevention of diseases. Bio-Targets and Drug Delivery Approaches is an easy-to-read book for students, researchers and...

Process Validation in Manufacturing of Biopharmaceuticals

3rd Edition

Anurag S. Rathore, Gail Sofer
May 09, 2012

Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as...

Pharmaceutical Process Scale-Up

3rd Edition

Michael Levin
February 02, 2011

The third edition of Pharmaceutical Process Scale-Up deals with the theory and practice of scale-up in the pharmaceutical industry. This thoroughly revised edition reflects the rapid changes in the field and includes: New material on tableting scale-up and compaction. Regulatory appendices that...

Pharmaceutical Water: System Design, Operation, and Validation, Second Edition

2nd Edition

William V. Collentro
December 21, 2010

A major new work on all aspects of water, the most used raw material ingredient in the pharmaceutical and biotechnology industries—used as an excipient in pharmaceutical formulations, as a cleaning agent, and as a separately packaged product diluent. Drawing on the author’s extensive field...

Validation of Pharmaceutical Processes

3rd Edition

James P. Agalloco, Frederick J. Carleton
September 25, 2007

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...

Validation and Qualification in Analytical Laboratories

2nd Edition

Ludwig Huber
July 23, 2007

This Second Edition discusses ways to improve pharmaceutical product quality while achieving compliance with global regulatory standards.  With comprehensive step-by-step instructions, practical recommendations, standard operating procedures (SOPs), checklists, templates, and graphics for easy...

Pharmaceutical and Medical Device Validation by Experimental Design

1st Edition

Lynn D Torbeck
June 26, 2007

This title demonstrates how designed experiments are the most scientific, efficient, and cost effective method of data collection for validation in a laboratory setting. Intended as a learn-by-example guide, Pharmaceutical and Medical Device Validation by Experimental Design demonstrates why...

Facility Validation: Theory, Practice, and Tools

1st Edition

Graham C. Wrigley
March 29, 2004

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,...

Electronic Record Keeping: Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164

1st Edition

David Nettleton, Janet Gough
December 29, 2003

The current revolution in software, and the regulations that have evolved to address it, have increasingly caused companies to turn to off-the-shelf software for electronic record keeping. Data captured in computerized systems must be as reliable, if not more so, than data on paper. Electronic...

Computer Systems Validation: Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies

1st Edition

Guy Wingate
December 18, 2003

Both pervasive and ubiquitous, computerized systems are now an integral component of every corporate strategy in pharmaceutical and healthcare companies. However, when technology is combined with high-risk public safety projects or the production and control of life-saving medicines or devices, it...

Conferences

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