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Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers, Volume 1 (Hardcover)
Book
**Winter Booksale: 50% OFF! Limited Quantity Available!** Following an introduction to the subject of Good Distribution Practice (GDP), the first volume of this book covers key topics related to five main points: the applicable GDP regulations worldwide, including serialization; an overview of the … -
Technical Report No. 83: Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness, and Response
PDF Single user
The purpose of this technical report is to describe the proven, successful principles used and measures that can be taken to mitigate the risk of contamination by viruses and to provide guidance in effective preparation and response should such an event occur in manufacturing processes using in vitro … -
Biotechnology: From Idea to Market (single user digital version)
PDF Single user
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 … -
Biotechnology: From Idea to Market (Hardcover)
Book
**Winter Booksale: 50% OFF! Limited Quantity Available!**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 … -
PDA Reporte Tecnico No. 13 (Revisado): Fundamentos de un Programa de Monitoreo Ambiental en Español
PDF Usuario Unico
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. PDA publicó por primera vez una guía sobre monitoreo ambiental en forma de Reporte … -
PDA Technical Series: Endotoxin Analysis and Risk Management
PDF Single user
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 … -
Technical Report No. 82: Low Endotoxin Recovery
PDF Single user
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. Available to download. Prior … -
Technical Report No. 81: Cell-Based Therapy Control Strategy
PDF Single user
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. Available to download. Prior to purchase please view the download instructions and Terms of Usage. Format: PDF (1 file 3.45 MB) Click … -
Biopharmaceutical Validation and Technical Transfer (single user digital version)
PDF Single user
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. Available to download. Prior to purchase please view the download … -
Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volume 2 (single user digital version)
PDF Single user
Clearance Sale - 20% off! Original Price US$235 PDA Member, US$289 Nonmember, US$155 Government Sale prices are already displayed and will be reflected during checkoutThe first edition of Microbiology in Pharmaceutical Manufacturing, published in 2001, is THE best selling PDA/DHI book of all time. … -
Risk Management Library Volume 7, Risk Problem Solvers: Inadequate Facilities, Procedures and Process Control (single user digital version)
PDF Single user
Pharmaceutical and Biopharmaceutical Manufacturing: Understanding Your Process Series The U.S. FDA plans to take a risk-based approach to biomanufacturing inspection and changes are expected very soon. With regulatory expectations and the impending changes anticipated in 21CFR 600 in June 2018, now is … -
Risk Management Library Volume 6, Risk Problem Solvers: Lack of Process Understanding (single user digital version)
PDF Single user
Pharmaceutical and Biopharmaceutical Manufacturing: Understanding Your Process Series The U.S. FDA plans to take a risk-based approach to biomanufacturing inspection and changes are expected very soon. With regulatory expectations and the impending changes anticipated in 21CFR 600 in June 2018, now is … -
Risk Management Library Volume 5, Risk Problem Solvers: Failure to Follow Established Procedures (single user digital version)
PDF Single user
Pharmaceutical and Biopharmaceutical Manufacturing: Understanding Your Process Series The U.S. FDA plans to take a risk-based approach to biomanufacturing inspection and changes are expected very soon. With regulatory expectations and the impending changes anticipated in 21CFR 600 in June 2018, now is … -
Risk Management Library Volume 4: Practical Approaches to Risk Assessment and Management Problem Solving: Tips and Case Studies (single user digital version)
PDF Single user
Pharmaceutical and Biopharmaceutical Manufacturing: Understanding Your Process Series The U.S. FDA plans to take a risk-based approach to biomanufacturing inspection and changes are expected very soon. With regulatory expectations and the impending changes anticipated in 21CFR 600 in June 2018, now is … -
Risk Management Library Volume 3: Practical Approaches to Risk Assessment and Management (single user digital version)
PDF Single user
Pharmaceutical and Biopharmaceutical Manufacturing: Understanding Your Process Series The U.S. FDA plans to take a risk-based approach to biomanufacturing inspection and changes are expected very soon. With regulatory expectations and the impending changes anticipated in 21CFR 600 in June 2018, now is … -
Risk Management Library Volume 2: Practical Approaches to Risk-Based Compliance (single user digital version)
PDF Single user
Pharmaceutical and Biopharmaceutical Manufacturing: Understanding Your Process Series The U.S. FDA plans to take a risk-based approach to biomanufacturing inspection and changes are expected very soon. With regulatory expectations and the impending changes anticipated in 21CFR 600 in June 2018, now is … -
Risk Management Library Volume 1: Lifecycle Risk Management (single user digital version)
PDF Single user
Pharmaceutical and Biopharmaceutical Manufacturing: Understanding Your Process Series The U.S. FDA plans to take a risk-based approach to biomanufacturing inspection and changes are expected very soon. With regulatory expectations and the impending changes anticipated in 21CFR 600 in June 2018, now is … -
Phase Appropriate GMP for Biological Processes: Pre-clinical to Commercial Production (single user digital version)
PDF Single user
This book provides succinct and practical guidance on how to develop a biological drug product and, at the same time, stay within the regulatory expectations at each phase of the development process!Within this book, you can find chapters on:Current manufacturing and process development of Regenerative … -
Contamination Prevention for Nonsterile Pharmaceutical Manufacturing
PDF Single user
The handbook on Contamination Prevention for Nonsterile Pharmaceutical Manufacturing offers guide-lines for best practices to be deployed within a manufacturing facility. It explains where the most common microbiological risks to nonsterile manufacturing reside and how to prevent contamination in the … -
Microbiological Culture Media: A Complete Guide for Pharmaceutical and Healthcare Manufacturers (single user digital version)
PDF Single user
Taking into account that 90 percent of quality control microbiology remains reliant upon culture based methods, this unique text focuses on microbiological culture media as applied to pharmaceutical microbiology. This book takes into consideration that innovations continue to arise with new media recipes …
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