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PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools
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This American National Standard (ANS) evaluates various guidance documents, models, and tools to measure and provide a better understanding of quality culture for the pharmaceutical/medical device industry. The standard identifies 5 key focus topics with attributes, characteristics, and measurements … -
PDA/ANSI Standard 03-2025: Standard Practice for Quality Risk Management of Aseptic Processes
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This standard provides a lifecycle approach using a holistic evaluation of contamination control systems designed to minimize and/or prevent contamination during aseptic processing and ultimately ensure the safety of the products when delivered to the patient. The standard is also applicable to aseptic … -
Conducting Compliant Investigations
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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 … -
Quality by Design - An Indispensable Approach to Accelerate Biopharmaceutical Product Development (single user digital version)
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PDA's book, Quality by Design — An Indispensable Approach to Accelerate Biopharmaceutical Product Development, edited by industry experts Cristiana Campa, Vaccines Technical R&D, GSK, and M. Amin Khan , Vaccines R&D, GSK, is an important contribution to the ongoing dialogue for accelerating … -
Technical Report No. 60-3: Process Validation: A Lifecycle Approach, Annex 2: Biopharmaceutical Drug Substances Manufacturing
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The concepts presented in PDA Technical Report No. 60-3 (TR 60-3): Process Validation: A Lifecycle Approach Annex 2: Biopharmaceutical Drug Substances Manufacturing are intended to assist in the design and implementation of globally compliant validation programs to ensure process reproducibility and … -
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 … -
Technical Report No. 13-2: Fundamentals of an Environmental Monitoring Program Annex 1: Environmental Monitoring of Facilities Manufacturing Low Bioburden Products
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PDA Technical Report No. 13-2 (TR 13-2) Fundamentals of an Environmental Monitoring Program Annex 1: Environmental Monitoring of Facilities Manufacturing Low Bioburden Products, is an addendum to PDA Technical Report No. 13 (TR 13, Revised 2014): Fundamentals of an Environmental Monitoring Program, which … -
Digital Transformation and Regulatory Considerations for Biopharmaceutical and Healthcare Manufacturers, Volume 1: Digital Technologies for Automation and Process Improvement (single user digital version)
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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 … -
Water Activity Applications in the Pharmaceutical Industry (single user digital version)
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This book examines the fundamentals and relationships of water activity, ranging from the measurement of moisture content, water activity, and water sorption isotherms, to ways in which water activity affects microorganisms, chemical reaction rates, drug product formulation and processing and physical … -
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 … -
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 … -
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 … -
Software as a Service (SaaS): Risk-Based Validation with Time-Saving Templates (single user digital version)
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From this book, you will learn a systematic, step-by-step approach for validating configurable off-the-shelf software that generates data or controls information about products and processes subject to regulations. You will also get access to templates the authors have used as training tools for more … -
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, … -
Managing the Pharmaceutical Cold Chain (single user digital version)
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This chapter is reprinted and available individually from Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers, Volume 1 edited by Siegfried Schmitt, a text that collects in one place invaluable and comprehensive regulatory, manufacturing and distribution guidance and … -
Toward an Integrated Cold Chain (single user digital version)
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This chapter is reprinted and available individually from Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers, Volume 1 edited by Siegfried Schmitt, a text that collects in one place invaluable and comprehensive regulatory, manufacturing and distribution guidance and … -
Serialisation Regulations in the EU and USA (single user digital version)
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This chapter is reprinted and available individually from Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers, Volume 1 edited by Siegfried Schmitt, a text that collects in one place invaluable and comprehensive regulatory, manufacturing and distribution guidance and … -
Quality Control Testing Throughout the Product Development Lifecycle (single user digital version)
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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 … -
Manufacturing Biopharmaceuticals From Start-Up to Commercialization (single user digital version)
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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 …
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