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Global Sterile Manufacturing Regulatory Guidance Comparison & Assessment Tool Second Edition
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Companies producing sterile drug products must remain compliant with all regulations and requirements for current good manufacturing practices (cGMP) for any country or region where they wish to manufacture and market their products. Each regulatory authority presents their requirements through differing … -
Technical Report No. 46 (Revised 2024) Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to End Users
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PDA Technical Report No. 46 (Revised 2024): Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to End Users complements the information provided in Technical Report No. 39 (Revised 2021): Guidance for Temperature-Controlled Medicinal Products — Maintaining the Quality … -
Points to Consider No.1 Aseptic Processing (Revised 2023)
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This document provides points to consider on topics related to the physical environment in which aseptic processing is conducted, monitoring of that environment, cleanroom personnel, material transfer, aseptic process simulation and validation, modern blow-fill-seal technology, cleaning, disinfection … -
Technical Report No. 90: Contamination Control Strategy Development
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Drug manufacturers have employed contamination control measures for decades as a core element of good manufacturing practices. Commonly, these are a collection of generic practices that were developed separately and applied without clear consideration for their interdependence. The ongoing evolution … -
Technical Report No. 89: Strategies for Vaccine Development
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This report describes different strategies that can be applied to manage the development and lifecycle of vaccine products. The concepts covered are intended to apply to different types of vaccines, for which "real world" examples are provided. In some cases, the strategy may involve extensive retrospective … -
Conducting Compliant Investigations (single user digital version)
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In this book you will find many different approaches to conducting compliant investigations, where compliant is defined as meeting the requirements of the applicable regulatory documents. The information it provides on conducting investigations that will be acceptable to regulatory investigators will … -
The Infamous Fungus: Enigmatic, Distinct and Misjudged (single user digital version)
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This chapter is taken from the book Fungi: A Handbook for Life Science Manufacturers and Researchers, edited by Jeanne Moldenhauer.There is a major gap in understanding fungi in general and mold specifically in the pharmaceutical industry. Most mycologists are in academia and fungi are not taught in … -
Digital Transformation and Regulatory Considerations for Biopharmaceutical and Healthcare Manufacturers, Volume 2: Digital Data, Insights, Metrics and Analytics (single user digital version)
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This second of two volumes details how pharmaceutical and healthcare manufacturers have ben embracing digital technologies as part of the transformation of their business models. It contextualizes current developments and future advancements in terms of the COVID-19 situation of 2020 and specific measures … -
Digital Transformation and Regulatory Considerations for Biopharmaceutical and Healthcare Manufacturers, Volume 1: Digital Technologies for Automation and Process Improvement (single user digital version)
PDF Single user
This first-of-two volume release from prolific author Tim Sandle fills an important void by taking an in-depth look at the way digital technologies are impacting the pharmaceutical and healthcare landscape both now and into the future. He explores how companies have been embracing digital technologies … -
Digital Transformation and Regulatory Considerations for Biopharmaceutical and Healthcare Manufacturers: Digital Technologies for Automation and Process Improvement (Hardcover)
Book
This first-of-two volume release from prolific author Tim Sandle fills an important void by taking an in-depth look at the way digital technologies are impacting the pharmaceutical and healthcare landscape both now and into the future. He explores how companies have been embracing digital technologies … -
Points to Consider for Implementation of Pre-Use Post-Sterilization Integrity Testing (PUPSIT)
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This Points to Consider document was developed as part of the PDA/BioPhorum Sterilizing Filtration Quality Risk Management Consortium. It provides the reader with points to consider on how to best implement and execute a pre-use/post-sterilization integrity test (PUPSIT) of the final sterilizing grade … -
Points to Consider for Risks Associated with Sterilizing Grade Filters and Sterilizing Filtration
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PDA's Points to Consider for Risks Associated with Sterilizing Grade Filters and Sterilizing Filtration summarizes the processes and outcomes of the risk Assessment and control mapping exercises performed as part of the PDA/BioPhorum Sterilizing Filtration Quality Risk Management Consortium. It describes … -
Root Cause Investigations for CAPA: Clear and Simple (single user digital version)
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This text, based on workshops led by instructor and author James Vesper, provides practical tools for both a thorough understanding of risk-based CAPA investigations and regulatory acceptable applications.Beginning with topics such as why and how much investigations matter, regulatory requirements, roles … -
Points to Consider for the Aseptic Processing of Sterile Pharmaceutical Products in Isolators
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Focusing on important regulatory and technical updates surrounding isolator design, validation, and operations for aseptic processing, this Points to Consider addresses two primary types of isolators - open and closed - and is intended to support identification and use of modern technology. It does not … -
Recalls of Pharmaceutical Products: Eliminating Contamination and Adulteration Causes (Hardcover)
Book
Are you prepared for recalls relating to pharmaceutical and healthcare medications and medical devices? This book contains details about recalls from start to finish, including advice on how to handle a recall and, more importantly, how they can be avoided. Read about regulatory perspectives, trends … -
5 Year Summary of FDA Drug 483s: 2015-2019 (single user digital version)
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This publication provides a summary and analysis of publicly available yearly observation data for drug product manufacturers from the U.S. FDA and presents it in a more useful, digestible format. It includes an analysis of trends in observations and a breakdown of the most common observations from … -
5 Year Summary of FDA Biologics 483s: 2015-2019 (single user digital version)
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The form FDA 483, "Inspectional Observations," is a form used by the FDA to document and communicate concerns discovered during the inspections of biological manufacturing plants. This booklet takes the publicly available yearly inspection data from the U.S. FDA and presents it in a more useful, … -
Key Features of a Biosafety Program for the Biopharmaceutical Industry (single user digital version)
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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 … -
Overview of Conventional and Emerging Microbial Identification Methods (single user digital version)
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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 … -
Quality Risk Management in the Context of Viral Contamination (single user digital version)
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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 …
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