PDA Publications
Encyclopedia of Rapid Microbiological Methods, Volume 4
Edited by: Michael Miller
Item Number: 17308
Encyclopedia of Rapid Microbiological Methods, Volume 4 , Rapid microbiological methods have made amazing strides recently and this volume complements Dr. Miller's previous three volumes by offering up-to-the-minute advances, new techniques, case studies, new equipment and much more. Contents of the Encyclopedia of Rapid Microbiological Methods, Volume 4 include details about: quality control, choosing appropriate methods, future use and technologies, mass spectrometry, genotypic methods for identification, new case studies, detection, application of USP and other guidelines, environmental monitoring, alternative tests, validation, sterility testing, mycoplasma testing, application of rapid microbiological methods as they relate to both bio-processing and regulatory considerations, many product-specific method advances and much, much more.
Date of Publication: January 2013. 292 Pages
Number of Pages: 608
Risk Assessment and Risk Management in the Pharmaceutical Industry Clear and Simple
Author: James L. Vesper
Item Number: 1571
Risk Assessment and Risk Management in the Pharmaceutical Industry: Clear and Simple, begins with history, definitions, how we think about risks and hazards, it gives overview of the risk management process and commonly used risk assessment methods and tools. It also explores the phases of the risk management process in detail and examines how the various tools can be applied in identifying hazards and evaluating their potential impact and affects. There are examples throughout the book that illustrate how the tools can be applied in "real life".
2006. Hardcover. 292 Pages.
Recent Warning Letters Review for Preparation of an Aseptic Processing Inspection
Author: Jeanne Moldenhauer
Item Number: 1572
The focus of this book is to provide a way to prepare for a FDA inspection of an aseptic facility by reviewing Warning Letters recently issued to pharmaceutical companies. The number of Warning Letters issued by FDA has been rising in recent years. The FDA publishes Warning Letters in its Electronic Reading Room available on its website (www.fda.gov). The problem is that it takes time to download and review the documents and look at them cohesively for their impact on your operation. This book has taken these observations and segregated them according to the applicable GMP requirements, making them easier to look at in a systematic fashion.
Based upon lengthy industry experience, Jeanne Moldenhauer has done the work for you by reviewing all relevant recent Warning Letters for aseptic processing topics and has identified areas of focus and interest for investigators, some of the types of issues deemed important by the investigator, and potential issues that may be applicable at an aseptic processing site.
This invaluable guide is a must read for all personnel involved in any way with the pharmaceutical aseptic processing inspection process.
2010. Hardcover. 194 pages.
Recent Warning Letters Review for Preparation of a Non-Sterile Processing Inspection, Volume 2
Author: Jeanne Moldenhauer
Item Number: 1573
The focus of this book is to provide a way to prepare for an FDA inspection of a non-sterile facility by reviewing relevant Warning Letters recently issued. The number of Warning Letters issued by FDA has been rising in recent years. The FDA publishes Warning Letters in its Electronic Reading Room available on its website (www.fda.gov). The problem is that it takes time to download and review the documents and look at them cohesively for their impact on your operation. This book has taken these observations and segregated them according to the applicable GMP requirements, making them easier to look at in a systematic fashion.
Based upon lengthy industry experience, Jeanne Moldenhauer has done the work for you by reviewing all relevant recent Warning Letters for non-sterile processing topics and has identified areas of focus and interest for investigators, some of the types of issues deemed important by the investigator, and potential issues that may be applicable at an aseptic processing site.
2010. Hardcover. 332 pages.
Environmental Monitoring A Comprehensive Handbook, Volume I, II, III, IV and Protocol CD
Author: Jeanne Moldenhauer
Item Number: 1574
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 Jeanne Moldenhauer provides guidance through the ins and outs of the multitudinous aspects of compliance. They are a must have for anyone involved in any way with environmental monitoring concerns.
These four volumes, with 84 chapters written by subject matter experts worldwide, describe methods for developing and operating an appropriate, sustainable microbiological program for production and the laboratory. Each volume is different insofar as each speaks about different environmental monitoring issues. Numerous useful protocols are included on CD.
Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volume I and II
Author: Richard Prince
Item Number: 1575
The first edition of Microbiology in Pharmaceutical Manufacturing, published in 2001, is THE best selling PDA/DHI book of all time. Modeled on the first edition, the 2008 completely revised and extended edition raises the bar by offering practical and current industrial and regulatory perspectives. While in revision, 20 new chapters were added and sixteen new authors contributed their work to this book making it the most comprehensive collection of best thinking from subject matter experts in their respective fields.
The goal of this book is to provide updated and expanded microbiological information for the benefit of a global audience of stakeholders.
Volume 1: 2008. 615 Pages. Hardcover. ISBN: 1-933722-19-3.
Volume 2: 2008. 482 Pages. Hardcover. ISBN: 1-933722-20-7.
Quality by Design Putting Theory Into Practice
Author: Siegfried Schmitt
Item Number: 1576
This book is written with all stakeholders in mind; the regulatory agencies and the healthcare industry, including their suppliers. As the process of adoption, implementation and interpretation of Quality by Design is currently the key driver to help industry bring products to market faster and at the same time provide maximum assurance of product quality. Though pharmaceutical companies need to abide the law and therefore comply with the applicable laws, rules and regulations, their goal must be to be profitable. A business case must therefore not only outline how compliance can be achieved, maintained and improved, but also how this will result in a positive financial impact.
Practical Aseptic Processing Fill and Finish, Volume I and II
Author: Jack Lysfjord
Item Number: 1577
Aseptic Processing technology has changed with the use of Advanced Aseptic Processing techniques such as: Blow fill seal (BFS) isolators and Restricted Access Barrier Systems (RABS). By becoming informed of the current state of the art, product contamination can be greatly improved. Products are changing with the increasing dominance of biological and biotech products being produced and it is imperative that manufacturers keep pace with these changes that can save time and money, improve productivity and increase safety. We all need to stay on top of "what is current?" Jack Lysfjord, together with more than 30 global subject matter experts, contributes invaluable pragmatic knowledge to this pursuit.
Volume 1: 447 pages.
Volume 2: 456 pages.
Validation by Design The Statistical Handbook for Pharmaceutical Process Validation
Author: Lynn D. Torbeck
Item Number: 1578
This book offers an overview of the statistical issues expressed and implied in the U.S. FDA`s Guidance for Industry Process Validation: General Principles and Practices, Draft, November 2008. The need for this book is illustrated by the many inquires the author receives about how to use and implement basic statistics and designed experiments, DOE, for pharmaceutical process validation. There is clearly confusion and concern about meeting general regulatory requirements and this book answers those questions. It is an invaluable resource for anyone concerned with statistical aspects of validating a drug, biologic or animal health manufacturing process.
2010. Hardcover. 222 pages.
Cleaning and Cleaning Validation, Volume 1
Author: Paul L. Pluta
Item Number: 1579
"Cleaning and Cleaning Validation" is a series of volumes containing current knowledge and approaches to cleaning and cleaning validation of pharmaceutical, medical devices, and associated products. Information provided will be consistent with current regulatory documents and expectations. Volumes will provide increasingly specific and detailed information, beginning with validation basics and culminating with a discussion of various topics in the lifecycle approach to cleaning process validation. Practical information and case studies presented throughout the volumes will supplement the basic information with useful experiences.
2009. Hardcover. 470 pages.
Laboratory Design Establishing the Facility and Management Structure
Author: Scott V. W. Sutton
Item Number: 1580
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 proficiency and careful data analysis.
2010. Hardcover. 387 pages.
Encyclopedia of Rapid Microbiological Methods, Volume I, II and III
Author: Michael J. Miller
Item Number: 1581
Microbiologists and management alike are working together to remove the perceived barriers to implementing RMM in their own companies. Other industry sectors (e.g., clinical, cosmetic and personal care, food and beverage, municipal water authorities) have employed RMM technologies to monitor microbiological control in their manufacturing operations for many years, and the pharmaceutical industry should learn from their experiences and successes.
Volume 1: 2005. 404 Pages. Hardcover. ISBN: 1-930114-85-0.
Volume 2 : 2006. 468 Pages. Hardcover. ISBN: 1-930114-86-9.
Volume 3 : 2006. 480 Pages. Hardcover. ISBN: 1-930114-87-7.