Publications
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Biotechnology: From Idea to Market (single user digital version)
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 alike in how to think about and to navigate the necessary development process for healthcare product candidates, including biologics, new chemical entities, and other related products that address medical need. This instructional text enables anyone at any level or in any sector of the industry to easily achieve a basic knowledge of the critical steps (or the questions to ask) to properly evaluate an idea or technology, develop a viable product candidate, and ultimately advance it to the marketplace. -
PDA Reporte Tecnico No. 13 (Revisado) Fundamentos de un Programa de Monitoreo Ambiental en Español (versión digital de un solo usuario)
El monitoreo ambiental es complementario a un programa de aseguramiento de esterilidad y es usado
para evaluar la efectividad de controles microbianos utilizados en la fabricación de productos
farmacéuticos estériles. -
Audit and Control for Healthcare Manufacturers: A Systems-Based Approach (single user digital version)
Audits are an important part of quality assurance and the quality management system. With the help of PDA's newest book, Audit and Control for Healthcare Manufacturers: A Systems-Based Approach, you can ensure the quality and
effectiveness of your processes, systems, and personnel is maintained throughout your organization! -
Audit and Control for Healthcare Manufacturers: A Systems-Based Approach (Hardcover)
Audits are an important part of quality assurance and the quality management system. With the help of PDA's newest book, Audit and Control for Healthcare Manufacturers: A Systems-Based Approach, you can ensure the quality and
effectiveness of your processes, systems, and personnel is maintained throughout your organization! -
PDA Technical Series: Endotoxin Analysis and Risk Management (single user digital version)
PDA Technical Series: Endotoxin Analysis and Risk Management is a collection of published research on the topic from the PDA Journal of Pharmaceutical Science and Technology. This volume is intended for those in the industry who perform and/or are responsible for the quality testing and manufacture of biopharmaceutical products. For those concerned with the phenomenon of "Low Endotoxin Recovery," two articles from the PDA Journal are included. -
PDA Technical Report No. 82 (TR 82) Low Endotoxin Recovery (single user digital version)
This Technical Report aims to describe the underlying mechanisms and contributing factors of LER, summarize the potential clinical impact of the LER phenomenon, present guidelines for developing LER hold-time study design, and provide strategies for the mitigation of LER. -
SOPs Clear and Simple: For Healthcare Manufacturers (single user digital version)
In this comprehensive guide, gain practical insight into the need for SOPs, how to write them, and what should be included in them. Explore the application of SOPs to the pharmaceutical, biotechnology, and medical device industries. This useful text offers a simple, yet, straightforward approach to writing SOPs, highlighting their importance in maintaining compliant operations critical to manufacturing quality products. -
SOPs Clear and Simple: For Healthcare Manufacturers (Hardcover)
In this comprehensive guide, gain practical insight into the need for SOPs, how to write them, and what should be included in them. Explore the application of SOPs to the pharmaceutical, biotechnology, and medical device industries. This useful text offers a simple, yet, straightforward approach to writing SOPs, highlighting their importance in maintaining compliant operations critical to manufacturing quality products. -
Environmental Monitoring, Protocol CD in PDF format
Environmental Monitoring written by authors with extensive experience in environmental monitoring and should provide practical guidance on how to establish and maintain a system that will be meaningful, manageable and defendable. -
PDA Technical Report No. 81 (TR 81) Cell-Based Therapy Control Strategy (single user digital version)
This TR focuses on the development of a risk-based control strategy adapted to cell-based therapy that can mitigate the risk of generating a product of poor quality. -
Cleaning SOPs: Five Proven and Validated SOPs (single user digital version)
Renowned global expert, Anne Marie Dixon-Heathman offers you invaluable details that will assist you in reducing the risk of surface contamination to processes and products. -
Biopharmaceutical Validation and Technical Transfer (single user digital version)
This document discusses why and how to validate and transfer a process. It offers a helpful example, includes protocol details and discusses non-traditional process validation, life cycle management, change management and much more.
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Contamination Control in Healthcare Product Manufacturing, Volume 5 (single user digital version)
The fifth volume to PDA's popular series, Contamination Control in Healthcare Product Manufacturing, explores practical approaches to leverage environmental monitoring data to improve performance, how to design a risk-based environmental monitoring program for non-sterile manufacturing, the clinical relevance of objectional microorganisms, and much more! -
PDA Technical Report No. 80 (TR 80) Data Integrity Management System for Pharmaceutical Laboratories (single user digital version)
This Technical Report, developed by subject matter experts from the global pharmaceutical industry and regulatory agencies, provides the framework and tools necessary to establish a robust data integrity management system to ensure data integrity for paper, hybrid, and computerized systems within the laboratory. It is intended to outline regulatory requirements and expectations, along with best industry practices, to ensure data integrity, to highlight common gaps in laboratory data management practices, and to recommend methods of remediation. -
GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry, Fifth Edition, Revised & Expanded (single user digital version)
GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry, Fifth Edition, Revised and Expanded examines 34 elements that are typically included in a modern pharmaceutical quality system including data Integrity. Each quality system element has an overview section, some risk-related questions, and 3-10 expectations. Each expectation is explored in a bit more detail and examples from GMP references from the US FDA, Health Canada, the European Union, the World Health Organization, and the International Conference on Harmonization (ICH) are presented. -
Microbial Control and Identification: Strategies Methods Applications (single user digital version)
In this text, expert microbiologists and biopharmaceutical industry leaders explore the role of microbial identification knowledge as a cornerstone in the concept of microbial and contamination control programs. Each chapter illustrates how microbial control programs for facilities, equipment, and personnel can have a positive impact on products and ultimately, patients. Not only does it provide valuable information for the new microbiologist, it also serves as the perfect reference for well-seasoned professionals. -
Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volume 2 (single user digital version)
The goal of this book is to provide updated and expanded microbiological information for the benefit of a global audience of stakeholders. -
Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volume 1 (single user digital version)
The goal of this book is to provide updated and expanded microbiological information for the benefit of a global audience of stakeholders. -
PDA Research: 2017 PDA Glass Quality Survey (single user digital version)
The 2017 Glass Quality Survey is designed to assist in the identification of glass container quality concerns and development of solutions to overcoming them. Survey topics include glass sampling and inspection practices, product complaints and recalls due to glass defects, and quality oversight. -
PDA Technical Report No. 14, (TR 14) Validation of Column-Based Chromatography Processes for the Purification of Proteins
This technical report provides a current industry perspective and scientific guidance on the validation of column-based separation processes for the purification of biopharmaceutical proteins.
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