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Edited by experts and written by global subject matter professionals, this vital addition to the Contamination Control series offers new chapters covering current, relevant information including:Regulatory changes relative to ISO 14644, Parts 1 and 2 Updates to ISO 11737-1 Risks of spores including preventive …

Edited by experts and written by global subject matter professionals, this vital addition to the Contamination Control series offers new chapters covering current, relevant information including:Regulatory changes relative to ISO 14644, Parts 1 and 2 Updates to ISO 11737-1 Risks of spores including preventive …

Whether you are a student, a newcomer to the pharmaceutical industry or a seasoned professional, the second edition of this book has something for everyone. The book presents a condensed overview of the regulatory systems and processes for marketing a drug product in the three major global regions: …

This new book provides a truly global perspective on data integrity and the solutions available to address this serious issue. It includes two main sections: the regulatory and historic background of data integrity, and practical advice on how to prevent or rectify data integrity breaches.Each chapter …

This book is a practical guide for the control of visible defects and contamination in pharmaceutical products. It is intended for the product inspectors and lab support personnel, as well as those who use inspection results or are responsible for inspection operations. Meant to familiarize and educate …

Sale - 20% off!Original Price US$210 PDA Member, US$259 Nonmember, US$190 Government Sale prices are already displayed and will be reflected during checkoutIn a passionate retrospective of a successful career built on thinking statistically and applying that approach to quality in pharmaceutical …

Russ Madsen and Maik Jornitz have assembled fascinating stories from renowned industry practitioners who share their global work experiences to highlight root cause analysis and problem solving. Each story is written as a brief lesson that begins with a statement of the problem, the steps taken to analyze …

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 …

Visual inspection continues to be a critical step in the manufacture and release of high quality injectable medicines. There is limited specific guidance on inspection methods or acceptance criteria which has led to a wide range of industry practices. This diversity is also to be expected given the variety …

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 of pharmaceutical and biological …

This publication presents the results of the PDA Quality Culture Metrics Surveys conducted in September and October 2014. Because similar questions were asked, two sets of results are shown side by side: those from the survey open to all PDA members and those from the survey sent to Heads of Quality …

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. 70, (TR 70) Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities identifies the systematic elements essential to assuring compliant cleaning and disinfection programs for aseptic and bioburden controlled manufacturing facilities and classified …

A trend is a series of events or data collected, generally over time, that has an established and expected pattern. The trend can be observed or it can be based on theoretical models. Any departure from the trend is then an unexpected out-of-trend event. It is atypical and begs for investigation. Trend …

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 …

Sale - 20% off! Original Price US$1,070 PDA Member, US$1,340 Nonmember, US$930 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$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, …