Bookstore Search

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 requirements of Qualified Persons and Responsible Persons in …

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 requirements of Qualified Persons and Responsible Persons in …

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 …

PDA has just released the 2019 Technology Transfer Industry Survey, designed to investigate current practices and learn how companies conduct technology transfers, including their technology transfer processes, knowledge and risk management systems, documentation, and business strategies.More than 250 …

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 …

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 …

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 …

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 …

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 …

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 …

There are four simple sentences that define the concept of compliance and its relationship to Standard Operating Procedures (SOPs) — Say what you do. Do what you say. Prove it. Improve it. Despite this concept seeming simple, the number one topic of 483 observations for biologics, drugs, and devices …

There are four simple sentences that define the concept of compliance and its relationship to Standard Operating Procedures (SOPs) — Say what you do. Do what you say. Prove it. Improve it. Despite this concept seeming simple, the number one topic of 483 observations for biologics, drugs, and devices …

Environmental monitoring programs are appropriate for manufacturing of sterile products and non-sterile products. The most stringent application of these procedures is for sterile products manufactured by aseptic processing, while less stringent procedures may be appropriately employed for terminally …

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 …

Cleaning and sanitization is a common 483 citing. The cleaning methods in these five SOPs have been proven and validated. They are based upon published information in US standards and ISO standards. Renowned global expert, Anne Marie Dixon-Heathman offers you invaluable details that will assist you …

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 …

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 …

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 …

The Long-Awaited Revision and Update of GMP in Practice is Here! Have you ever asked yourself, "Where in the Good Manufacturing Practices (GMPs) does it say I have to do _______?" If so, look no further than PDA's GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry, fifth …

In PDA's latest release, 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. This book is an excellent reference for new microbiologists and seasoned professionals …