Pharmaceutical Science

Validation

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Bio-Targets and Drug Delivery Approaches

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, Third 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, Third 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

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...

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

Syed Imtiaz Haider
July 30, 2010

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...

The Pharmaceutical Regulatory Process, Second Edition

Ira R. Berry, Robert P. Martin
December 02, 2008

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...

Validation of Pharmaceutical Processes, Third 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, Second 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

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...

Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries

Syed Imtiaz Haider
May 30, 2006

Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production....

Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing

John Andrews
August 03, 2005

All too often, the words "computer validation" strike terror into the hearts of those new to the process and may even cause those familiar with it to tremble. Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing delineates GCP, GLP, and GMP regulatory requirements...

Write It Down: Guidance for Preparing Effective and Compliant Documentation

Janet Gough
March 30, 2005

A well-understood tenet exists among the FDA and other regulatory bodies: if you didn't write it down, it didn't happen. And if it didn't happen, your company stands to lose time, money, and perhaps its competitive edge. Write it Down: Guidance for Preparing Effective and Compliant Documentation...

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