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GMP - Cleaning and Cleaning Validation in the pharmaceutical industry
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Qualification / Validation

Cleaning and Cleaning Validation
€ 470.00
net
€ 502.90
  7% VAT included
Hardcover, 2 Volumes
US$
670.00
Volume 1 and 2
Edition: Volume 1: 2009 | Volume 2: 2013
Volume 1: 470 Pages | Volume 2: 592 Pages
Cleaning and Cleaning Validation is a series of volumes containing current knowledge and approaches to cleaning and cleaning validation of pharmaceuticals, medical devices, and associated products. Information provided is consistent with current regulatory documents and expectations. Practical information and case studies presented throughout the volumes will supplement the basic information with useful experiences.

Volume 1 in this series, "Basics, Expectations, and Principles," provides general information applicable to the entirety of cleaning and cleaning validation.

Volume 2, "Application of Basics and Principles," builds on the foundation of concepts provided in volume one and includes forty case studies. It begins by discussing the lifecycle approach to cleaning validation, an extension of the recently introduced FDA guidance of process validation. Additional discussions include: API residues, vaccine residues, polymers, sterile products, respiratory products, transdermal products, medical devices, and reagent products. It also includes equipment design considerations for cleaning, equipment sampling, spray coverage testing using riboflavin, and other equipment-related topics. A section on analytical aspects of cleaning validation discusses Process Analytical Technology (PAT) applications, sampling, protein residue characterization, the master soils concept for biotech products, and swab sampling training and sampler certification. Quality systems topics discuss the quality systems approach to cleaning and cleaning validation, change management in cleaning, and control charting fundamentals. An analytical cleaning laboratory gap analysis is described. The book culminates with a global perspective on common problems in cleaning and cleaning validation and describes frequent problems observed by the authors.

Table of Contents

Cleaning and Cleaning Validation.pdf
Paul L. Pluta, Ph.D., is a pharmaceutical scientist with extensive industrial development, manufacturing, and management experience. He has been involved in nearly all phases of product development and manufacturing for small molecule dosage forms. His validation experience includes manufacturing process validation, cleaning validation, and qualification of associated support systems. Dr. Pluta is also Associate Professor of Biopharmaceutics at the University of Illinois at Chicago (UIC) College of Pharmacy. Dr. Pluta edited and authored chapters in Cleaning and Cleaning Validation, Volume 1, Basics, Expectations, and Principles, published by PDA and DHI Publishing.
PDA/DHI Publication
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