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Clearance Sale! Original Price US$240 PDA Member, US$299 Nonmember, US$190 Government Sale prices are already displayed and will be reflected during checkoutHere, in one volume, is a unique compilation rich with vital information. Mary Griffin and Dona Reber have assembled a team of subject matter experts …

Contamination Control in Healthcare Product Manufacturing, Volume 1, edited by Russell E. Madsen and Jeanne Moldenhauer, is primarily focused on microbiological contamination and the methods used to monitor and control it, a secondary focus looks at chemical contamination that may result from the use …

Sale - 20% off! Original Price US$210 PDA Member, US$259 Nonmember, US$170 Government Sale prices are already displayed and will be reflected during checkoutThe goal of this book is to provide the reader with a well-rounded exposure to the unique aspects and considerations for implementation of cGMP …

This is a collection of selected articles on the integrity assessment of container/closure systems in drug or biological products and/or medical devices. These articles originate from the PDA Journal of Pharmaceutical Science and Technology published from 1985 to 1995 and were selected for inclusion …

The Microbiology and Engineering of Sterilization Processes, Twelfth Edition is a reference book and quality manual for the microbial-control area. The technical operations necessary to carry out the microbial-control process involves the discipline of microbiology and engineering; consequently, a …

This book discusses the basic concepts necessary to the understanding of Biological Indicators and includes the history of biological validation and general principles, the kinetics of microbial inactivation and factors affecting resistance as well as guidance in understanding bacterial endospores …

Variability is more than just the ‘noise in the system.’ It represents an insidious threat to companies, ranging from the reliability of their product lines to the strength of their financial bottom-lines. The understanding of variability sources, therefore, can provide a solid framework for …

Pharmaceutical Quality is a collection of essays that offer an examination of quality from the perspectives of senior experts working in industry, government and academia from around the world. Pharmaceutical Quality enriches our recognition of what quality is, or what we think it is. I. Section One …

Clearance 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 …

Clearance 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 edited by Jeanne Moldenhauer adds to the wealth of knowledge provided in the previous volumes by addressing several important …

This comprehensive book provides step-by-step guidance needed to develop and implement a compliant validation program based on current ANSI/AAMI/ISO standards. It includes discussion of parametric release, reduced Biological Indicators (BI) incubation, support testing and much more.Available …

The Validation Master Plan is used for many different purposes by different companies and by different production sites within the same company. Within the countries governed by the Pharmaceutical Inspection Cooperation Scheme (PICS), there is a current move to define what is required of a …

Dr. Michael Jahnke, Head of Microbiology at Pharma Hameln GmbH, introduces you to the subject of environmental monitoring of pharmaceutical areas. Major topics covered include: Cleanrooms including discussions of zones, classifications, assignment of production rooms; Air-handling systems; Causes of …

The second in this series of four books. Provides current, practical techniques that focus on considerations in the preparation and monitoring of aseptic manufacturing, taking into account the national and international requirements, and guidelines concerning the validation of aseptic processing. The …

Here is the guidance you need to host a compliance inspection. This book provides a common-sense approach for assessing an incoming inspection and preparing for it, regardless of who is conducting the inspection. Company and country cultures vary greatly, as do the regulations driving …

The companion to The Internal Quality Audit, this book performs the same valuable function by helping you focus on issues specific to your suppliers, contractors, and consultants. External audits help you ensure that each supplier consistently provides valuable services that enhance your …

Here is the common-sense guidance you need to perform an effective, systematic internal quality audit. As a quality professional, you are well aware of the repercussions caused by a nonconforming product entering the marketplace; customers may experience adverse effects or worse, and your company …

This monograph clearly explains the Limitation of Risk Method (LR-Method). When a systematic risk analysis is performed and sampling locations are selected and evaluated in a rational manner using this method, comprehensive monitoring will reduce the number of microbiological samples necessary and provide …

Following a discussion of the regulations to be followed in the microbiological control of water processing and distribution systems, this work focuses on practical aspects in the pharmaceutical environment and gives advice on the methodology to be used, e.g., for sampling, the selection of nutrient …

PDA's latest professional resource, Biotechnology: From Idea to Market, is an invaluable guide and reference for anyone involved in the development of a product, from idea generation through commercialization. The goal of this book is to provide this comprehensive overview for students and professionals …