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Building Value into Biotechnology Development and ManufacturingThe magnitude of knowledge and experience required to have a meaningful impact on biotechnology product approvals and market success is monumental. For the first time, expertly crafted chapter is reprinted from Biotechnology From Idea to …

Here are robust discussions of microbial identifications in a new light.This reprint from Microbial Control and Identification: Strategies, Method and Applications edited by Dona Reber and Mary Griffin demonstrate how microbial identification knowledge is a cornerstone in the concept of microbial and …

Building Value into Biotechnology Development and ManufacturingThe magnitude of knowledge and experience required to have a meaningful impact on biotechnology product approvals and market success is monumental. For the first time, expertly crafted chapter is reprinted from Biotechnology From Idea to …

Help Solving Manufacturing Process ProblemsRussell Madsen and Maik Jornitz have assembled and edited fascinating stories of incidents from their own experiences and those of other long serving industry practitioners and experts. Reprinted from their text: Lessons of Failure: When Things Go Wrong in Pharmaceutical …

The best way to handle Warning Letters issued by the U.S. FDA is to prevent them. This text identifies and discusses those Letters recently issued, offers analysis, and provides guidance to help readers avoid receiving such a letter.In addition to the Warning Letter summaries there is discussion of …

PDA Technical Report No. 54-6, Risk Assessment for Excipients, is the sixth technical report (TR) in the TR 54 series related to various aspects of Quality Risk Management (QRM). It was developed to provide additional guidance on the excipient risk assessment process required by the European Commission …

This text can help identify and ameliorate fungal and mold problems and contains a wealth of information as a guide and reference. Many topics are discussed relevant to the food and agriculture industries, including the biology of fungi, outbreaks associated with pharmaceutical drug products and medical …

Clearance Sale - 20% off! Original Price US$225 PDA Member, US$279 Nonmember, US$180 Government Sale prices are already displayed and will be reflected during checkoutRisk-Based Software Validation: Ten Easy Steps, offers a systematic, ten-step approach, from the decision to validate to the assessment …

Following an introduction to the subject of Good Distribution Practice (GDP), in the second volume, dive into supply-chain risk mitigation, serialization, and packaging as it relates to risk assessments. This text and its companion Volume 1 will help drive down costs and improve efficiency.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 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 …

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 …

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 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 …