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The Bacterial Endotoxins Test: A Practical Guide (single user digital version)
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This unique book is a collection of interdependent chapters that are part lab manual, part essay, part historical context, part consultant and part plain sage advice that provide a practical and compliant approach to the execution and use of BET. Full of sensible technological and compliance advice … -
Quality By Design: Putting Theory Into Practice (single user digital version)
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Sale! Original Price US$210 PDA Member, US$259 Nonmember, US$155 Government Sale prices are already displayed and will be reflected during checkoutThis book is written with all stakeholders in mind; the regulatory agencies and the healthcare industry, including their suppliers. As the process of … -
Technology and Knowledge Transfer: Keys to Successful Implementation and Management (single user digital version)
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Written by global subject matter experts, this book offers the practical experience needed to obtain a competitive edge. The successful technology transfer from research and development to the commercial production site is a critical process in the development and launch of a new medicinal product. An … -
Cleanroom Microbiology (single user digital version)
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While there are books on cleanrooms available, these focus almost entirely on the physical and rarely address microbiological risks. Similarly, there are various books on microbiology (even a few about pharmaceutical microbiology), yet these books rarely mention cleanrooms, or, where they do, give controlled … -
PDA Technical Report No. 54-4, (TR 54-4) Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations: Annex 3: Case Studies in the Mfg of Biotechnological Bulk Drug Substances (single user digital version)
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The goal of Annex 3: Case Studies in the Manufacturing of Biotechnological Bulk Drug Substances is to provide detailed examples of characteristic operations and case studies that demonstrate the value of implementing QRM to effectively manage risks during manufacturing of biotechnological bulk drug … -
Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Volumes 1, 2 & 3 (single user digital version)
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Sale - 20% off! Original Price US$635 PDA Member, US$790 Nonmember, US$435 Government Sale prices are already displayed and will be reflected during checkoutThe three volumes Cleaning Validation: Practical Solutions for Pharmaceutical Manufacturing by Destin LeBlanc contains a complete, modified and … -
PDA Survey: 2014 PDA Process Validation Survey (single user digital version)
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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 … -
Environmental Monitoring: A Comprehensive Handbook, Volume 3 (single user digital version)
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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 … -
Environmental Monitoring: A Comprehensive Handbook, Volume 2 (single user digital version)
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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 … -
Environmental Monitoring: A Comprehensive Handbook, Volume 1 (single user digital version)
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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 … -
Contamination Control in Healthcare Product Manufacturing, Volumes 1, 2 & 3 (single user digital version)
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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 (single user digital version)
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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 … -
Contamination Control in Healthcare Product Manufacturing, Volume 3 (single user digital version)
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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 … -
PDA Technical Report No. 67, (TR 67) Exclusion of Objectionable Microorganisms from Nonsterile Pharmaceuticals, Medical Devices, and Cosmetics (single user digital version)
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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 … -
Risk-Based Compliance Handbook (single user digital version)
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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 needed … -
Systems Based Inspection for Pharmaceutical Manufacturers (single user digital version)
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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, sold, and … -
Cleaning and Disinfection (single user digital version)
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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 … -
Contamination Risk Assessment (single user digital version)
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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 … -
Validation of Analytical Methods for Biopharmaceuticals: A Guide to Risk-Based Validation and Implementation Strategies (single user digital version)
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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 … -
Particulate Matter in Injectable Drug Products (single user digital version)
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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 …
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