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PDA Technical Report No. 73 (TR 73) Prefilled Syringe User Requirements for Biotechnology Applications discusses the requirements for the 1 mL long glass prefilled syringe (PFS) for biotechnology applications.Over the past decade, a large number of subcutaneously injected biotechnology drug products …

**Winter Booksale: 25% OFF!**PDA Technical Report No. 72 (TR 72) Passive Thermal Protection Systems for Global Distribution: Qualification and Operational Guidance discusses the qualification and operational handling of passive thermal protection systems (TPS) for temperature-controlled distribution …

Technical Report No. 71, Emerging Methods for Virus Detection describes and critically assesses methods currently used for the detection of potential adventitious viruses in biomedicinal products and their production processes. It also details new methods that have emerged as a result of technological …

PDA Technical Report No. 69, (TR 69) Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations presents the current scientific understanding of the causes of and control strategies for bioburden in pharmaceutical production systems, with a special emphasis on biofilms in fluid-handling …

The past decade has seen a global emphasis on environmental monitoring. Regulatory bodies worldwide have all established standards and guidelines for environmental control. Unfortunately, the requirements are not equivalent among documents and nations. The Environmental Monitoring series edited by …

Sale - 20% off! Original Price US$800 PDA Member, US$1,000 Nonmember, US$700 Government Sale prices are already displayed and will be reflected during checkoutThe past decade has seen a global emphasis on environmental monitoring. Regulatory bodies worldwide have all established standards and guidelines …

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 checkoutThe past decade has seen a global emphasis on environmental monitoring. Regulatory bodies worldwide have all established standards and guidelines …

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 volume adds to the wealth of knowledge provided in the previous volumes by addressing several important issues not previously discussed in …

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 checkoutAn essential addition to this valuable series, Volume 6 offers current information about numerous subjects including E.M. computerized systems, …

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 is volume 7 of the Environmental Monitoring Handbook series. Each volume of this series discusses different aspects of environmental …

The Barr Decision (Barr, 1993) forever changed how pharmaceutical companies look at data that is out-of-specification (OOS). Following issue of this legal decision, many companies and regulators worked to determine how this decision affects microbiological test results.Microbial Risk and …

This Technical Report provides practical, risk-based guidance for the development and qualification portions of the analytical method lifecycle for biotechnology products. Method development begins with defining the requirements for the analytical method and leads to, but does not necessarily finish …

Clearance Sale! Original Price US$335 PDA Member, US$419 Nonmember, US$290 Government Sale prices are already displayed and will be reflected during checkoutRapid microbiological methods have made amazing strides recently and this volume complements Dr. Miller's previous three volumes by offering …

Sale - 20% off! Original Price US$795 PDA Member, US$989 Nonmember, US$685 Government Sale prices are already displayed and will be reflected during checkoutBuy All 3 Volumes and Save 20% Microbiologists and management alike are working together to remove the perceived barriers to implementing RMM in …

The current compendial sterility test methodology has been fully harmonized for Europe, Japan and the United States for many years. In spite of having a fully harmonized test methodology, in reality, the test methodology is only effective in detecting gross contamination in a batch of product. Manufacturers …

Clearance Sale! Original Price US$375 PDA Member, US$465 Nonmember, US$250 Government Sale prices are already displayed and will be reflected during checkoutThe first edition of Microbiology in Pharmaceutical Manufacturing, published in 2001, is THE best selling PDA/DHI book of all time. Modeled on …

This book focuses on the design procedures that minimize the likelihood of error. It also explains how to design the laboratory facility to maximize the ability of staff to get their work done in an efficient and effective manner by describing the best practices available for design planning, technical …

This book provides guidance in preventing and controlling Biofilm contamination in pharmaceutical and biopharmaceutical processing. Twelve chapters contributor by global experts and useful appendices cover topics such as the Contamination Control by Design Model, the impact of biofilms on pharmaceutical …

Sale - 20% off! Original Price US$255 PDA Member, US$319 Nonmember, US$160 Government Sale prices are already displayed and will be reflected during checkoutRisk Assessment and Risk Management in the Pharmaceutical Industry: Clear and Simple, begins with history, definitions, how we think about risks …

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 …