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This benchmarking survey was designed to solicit feedback on and industry status on the application of the principles established in the FDA Process Validation Guidance for Industry of 2011. The survey also investigated how companies are implementing the new lifecycle approach to process validation and …

Sale - 20% off! Original Price US$335 PDA Member, US$419 Nonmember, US$290 Government Sale prices are already displayed and will be reflected during checkoutThis book addresses current scientific, regulatory and technology environmental monitoring concerns for both aseptic processing and isolation …

Sale - 20% off! Original Price US$335 PDA Member, US$419 Nonmember, US$290 Government Sale prices are already displayed and will be reflected during checkoutEnvironmental monitoring programs are appropriate for manufacturing of sterile products and non-sterile products. The most stringent application …

Sale - 20% off! Original Price US$335 PDA Member, US$419 Nonmember, US$290 Government Sale prices are already displayed and will be reflected during checkoutEnvironmental monitoring programs are appropriate for manufacturing of sterile products and non-sterile products. The most stringent application …

50 global subject matter experts share their broad experience in all aspects of healthcare product manufacturing contamination control in this three-volume set.The first volume of Contamination Control contained chapters that are predominantly centered on microbial issues. Volume 2 addresses some microbial …

Contamination Control in Healthcare Product Manufacturing, Volume 2, edited by Russell E. Madsen and Jeanne Moldenhauer, Volume 2 addresses some microbial control issues as well as other types of contamination. These valuable chapters will provide a great deal of information in your arsenal for contamination …

Volume 3 discusses extensive subjects related to water considerations and also includes invaluable advice regarding ventilation systems, the microbiology laboratory, mold, microaerophillics, Burholderia cepacia, a life cycle approach to cleaning validation, extensive coverage of risk management with …

The purpose of TR 67 is to provide guidance to the nonsterile product manufacturing industry on how to manage the microbial risks associated with manufacturing and storage as well as how to determine what isolates would be deemed an objectionable microorganism in nonsterile products.This document is …

PDA TR 66 discusses single-use systems that are in either direct or indirect contact with raw materials, intermediates, and pharmaceutical drug substances or drug products and is intended to provide the reader with critical concepts or points to consider when implementing an single use system strategy …

The application of risk management to the processes within the healthcare industry is not just good practice, but an essential must do for any competitive and compliant enterprise. Whereas the ICH Q9 guideline "Quality Risk Management" describes the fundamental concepts, additional information is …

Training of new employees in a pharmaceutical company almost always includes instilling a 'healthy fear' of inspections conducted by regulatory agencies. Most, if not all, countries in the world have governmental agencies responsible for the safety and efficacy of the medicines manufactured, …

Written by subject matter experts, these chapters are organized by topic and excerpted from volumes in the Contamination Control in Healthcare Manufacturing seriesFacility Design and Control: Personnel by Anne Marie Dixon. Chapter excerpted from Volume 1, Chapter 5 published May 2013. Fungal and Bacterial …

Written by subject matter experts, these chapters are organized by topic and excerpted from volumes in the Contamination Control in Healthcare Manufacturing seriesFacility Design and Control: Cleaning and Sanitization by Anne Marie Dixon. Chapter excerpted from Volume 1, Chapter 6 published May …

Written by subject matter experts, these chapters are organized by topic and excerpted from volumes in the Contamination Control in Healthcare Manufacturing seriesContamination Control Risk Assessment by Tim Sandle. Chapter excerpted from Volume 1, Chapter 18 published May 2013. Contamination Risks …

Written by subject matter experts, these chapters are organized by topic and excerpted from volumes in the Contamination Control in Healthcare Manufacturing seriesFungal and Bacterial Spores: Contamination and Disinfection by Jim Polarine, Carol Bartnett and Dan Klein. Chapter excerpted from Volume …

Written by subject matter experts, these chapters are organized by topic and excerpted from volumes in the Contamination Control in Healthcare Manufacturing seriesDesign and Sanitization of Water Systems to Prevent Contamination by Teri C. Soli. Chapter excerpted from Volume 3, Chapter 2 published June …

The book contains many new practical tips, tools and case studies that will allow validation scientists and management to make good risk-based decisions during planning, execution and post-implementation changes for all projects. This book is centered on what "sufficient performance" and "suitable for …

This chapter is taken from the book Contamination Control in Healthcare Product Manufacturing, Volume 2 This chapter describes some of the sources of particulate matter contamination in injectable drugs and the clinical effects that can result from such contamination. It also reviews the development …

This chapter is taken from the book Combination Products: Implementation of cGMP RequirementsThis document discusses the complications related to developing combination products and gives details that help manufacturers understand risks and meet the regulatory requirements for such products. Available …

This chapter is taken from the book Quality By Design: Putting Theory Into PracticeThis subject matter expert discusses the QbD process as it applies to successful integration of this method with newer concepts such as Critical Quality Attributes (CQA), Critical Process Parameters (CPP) and design space …