Publications
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Encyclopedia of Rapid Microbiol Methods, Volume 4
This volume complements the author’s previous three volumes by offering new techniques, case studies, new equipment and much more. Details about quality control, choosing appropriate methods, future use and technologies, mass spectrometry are included.
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Encyclopedia of Rapid Microbiological Methods, Volumes 1, 2 and 3 (single user digital version)
Introductory volumes of the Encyclopedia of Rapid Microbiological Methods series focus on regulatory initiatives currently in place that will help pharmaceutical microbiologists begin the journey of implementing rapid microbiological methods in their facilities. The many rapid methods currently available are also described.
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Cleaning and Cleaning Validation, Volumes 1 and 2 (single user digital version)
"Cleaning and Cleaning Validation" is a series of volumes containing current knowledge and approaches to cleaning and cleaning validation of pharmaceuticals, medical devices and associated products, consistent with current regulatory documents and expectations. Case studies presented throughout the volumes supplement basic information with useful real-life experiences.
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Rapid Sterility Testing (single user digital version)
In this book you will find a history of the sterility test methodology as well as detailed discussions that provide the regulatory requirements and allowances for gaining approval of rapid sterility test methods. -
Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volumes 1 and 2 (single user digital version)
The first edition of Microbiology in Pharmaceutical Manufacturing, published in 2001, is THE best selling PDA/DHI book of all time. The completely revised and extended edition raises the bar by offering practical and current industrial and regulatory perspectives. Twenty new chapters were added and 16 new authors contributed their expertise provide updated and expanded microbiological information for the benefit of a global audience of stakeholders.
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Practical Aseptic Processing Fill and Finish, Volumes 1 and 2 (single user digital version)
Aseptic processing technology has changed with the use of advanced aseptic processing techniques such as blow/fill/seal isolators and restricted access barrier systems. This book explores these changes and how they impact the aseptic processing
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Thermal Validation in Moist Heat Sterilization (single user digital version)
The various authors cited in this book have a wealth of practical experience in thermal validation of moist heat sterilization processes that has been incorporated into their writing. This book is an essential guide and reference for managers, supervisors and all others concerned with preparing validation plans acceptable to regulators worldwide. -
Validating Enterprise Systems: A Practical Guide (single user digital version)
This book describes the latest tools, techniques and regulatory information needed to validate enterprise systems.
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Laboratory Design: Establishing the Facility and Management Structure (single user digital version)
This book is unique in looking at the question of lab design from a purely microbiological perspective and offers concrete direction to setting up your systems and facilities to minimize errors and data variability.
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Validation by Design: The Statistical Handbook for Pharmaceutical Process Validation (single user digital version)
This book addresses the statistical issues expressed and implied in the U.S. FDA`s Guidance for Industry Process Validation: General Principles and Practices, Draft, November 2008. -
Biofilm Control in Drug Manufacturing (single user digital version)
This book provides guidance in preventing and controlling Biofilm contamination in pharmaceutical and biopharmaceutical processing. -
Sterility Testing of Pharmaceutical Products (single user digital version)
The aim of the book is to present the sterility test as a final product release test as seen in the past, the present and with a view towards the future and is aimed at quality assurance personnel, production staff, microbiologists, students and those with an interest in medicinal products. -
Risk Assessment and Risk Management in the Pharmaceutical Industry: Clear and Simple (single user digital version)
Defines risk, discusses hazards and risks, and provides tools to evaluate risk, while providing the background and context necessary to understand the concept of risk management detailed in the regulatory guidance documents and to develop effective strategies for dealing with risk in the pharmaceutical industry. -
The Bacterial Endotoxins Test: A Practical Guide (single user digital version)
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. -
Quality By Design: Putting Theory Into Practice (single user digital version)
Quality by Design 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.
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Pharmaceutical Outsourcing: Quality Management and Project Delivery (single user digital version)
This book is intended to set forth and explore the best practices for contract organizations from various perspectives: the contract organization, the contracting organization and the regulators. The editors and authors have experience with outsourcing and have published a comprehensive, practical guide with the goal of offering sound, reasonable advice to the outsourcing community, focusing mainly on contract manufacturing.
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Technology and Knowledge Transfer: Keys to Successful Implementation and Management (single user digital version)
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 unsuccessful transfer can result in possible launch delays and lost sales and require increased resources, time and money to make corrective actions. This book will help companies take a proactive approach to streamlining and optimizing their technology transfer processes to ensure successes
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Cleanroom Microbiology (single user digital version)
This book is about cleanrooms and controlled environments in relation to the pharmaceutical and healthcare sectors. With its focus on cleanroom microbiology, this book is applicable to both the sterile and non-sterile pharmaceutical sectors.
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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)
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 substances. -
Square Root of (N) Sampling Plans: Procedures and Tables for Inspection of Quality Attributes (single user digital version)
The goal of Lynn and Joyce Torbeck's book, Square Root of (N) Sampling Plans: Procedures and Tables for Inspection of Quality Attributes, is to show that the sqrt (N) plans are statistically correct and can be used in applications that minimize risk to the patients.
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