Publications
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Digital Transformation and Regulatory Considerations for Biopharmaceutical and Healthcare Manufacturers: Digital Technologies for Automation and Process Improvement (Hardcover)
This first-of-two volume release takes an in-depth look at the digital technologies that are impacting the pharmaceutical and healthcare landscape now and into the future. It explores what each technology does, the potential use of the technology and the practical aspects for its implementation, along with the changes to culture and structure necessitated by digital transformation. This first volume covers process-centric themes and related regulatory aspects and standards.
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Water Activity Applications in the Pharmaceutical Industry (single user digital version)
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 properties, water activity as a hurdle, and applications of water activity management in the pharmaceutical industry.
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PDA Technical Report No. 84 (TR 84) Integrating Data Integrity Requirements into Manufacturing & Packaging Operations (single user digital version)
PDA Technical Report No. 84 (TR 84): Integrating Data Integrity Requirements into Manufacturing and Packaging Operations addresses data integrity from the perspective of manufacturing operations. It discusses regulatory trends, risk management concepts, and recommendations for implementing appropriate data integrity controls in manufacturing operations applicable to paper-based, electronic-based, and hybrid systems. The case studies included in this technical report provide examples of how to assess current data integrity risks and implement the concepts presented in the report.
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Points to Consider for Implementation of Pre-Use Post-Sterilization Integrity Testing (PUPSIT) (single user digital version)
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 liquid filters for products that are not terminally sterilized.
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Points to Consider for Risks Associated with Sterilizing Grade Filters and Sterilizing Filtration (single user digital version)
PDA's Points to Consider for the 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 the identification of the sterilizing filtration value stream throughout the process.
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Points to Consider for Sensitivity to Oxidation by Peroxide (single user digital version)
PDA’s Points to Consider for Sensitivity to Oxidation by Peroxide addresses aspects to consider in the design, development, processing, instrumentation, materials, and equipment specific to issues with products sensitive to oxidation when exposed to H2O2. This document primarily applies to isolator systems, where vapor phase hydrogen peroxide (VPHP) or vaporized hydrogen peroxide (VHP) is used to decontaminate the system. Current issues and approaches to consider for an oxidation-sensitive product are summarized, and industry experts outline best practices for developing a manufacturing process for drug product.
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Root Cause Investigations for CAPA: Clear and Simple (single user digital version)
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.
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Points to Consider for the Aseptic Processing of Sterile Pharmaceutical Products in Isolators
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 represent a standard or regulatory guidance.
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Software as a Service (SaaS): Risk-Based Validation with Time-Saving Templates (single user digital version)
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.
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Software as a Service (SaaS): Risk-Based Validation with Time-Saving Templates (Hardcover)
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. -
Recalls of Pharmaceutical Products: Eliminating Contamination and Adulteration Causes (single user digital version)
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 and primary causes for product recalls, notable recalls and lessons, quality metrics, and supply chain risk management. You can also find relevant information designed to help about labels, packaging, data integrity, methods to ensure GDP, and other industry best-practices. -
Recalls of Pharmaceutical Products: Eliminating Contamination and Adulteration Causes (Hardcover)
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 and primary causes for product recalls, notable recalls and lessons, quality metrics, and supply chain risk management. You can also find relevant information designed to help about labels, packaging, data integrity, methods to ensure GDP, and other industry best-practices. -
ANSI/PDA Standard 001-2020: Enhanced Purchasing Controls to Support the Bio-Pharmaceutical, Pharmaceutical, Medical Devices and Combination Products Industries (single user digital version)
A standard guidance for the selection and control of suppliers of purchased goods and services that can impact product quality and patient safety.
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5 Year Summary of FDA Medical Device 483s: 2015-2019 (single user digital version)
The form FDA 483, "Inspectional Observations," is a form used by the FDA to document and communicate concerns discovered during the inspections of medical device manufacturing plants. This booklet takes the publicly available yearly inspection data from the U.S. FDA and presents it in a more useful, digestible format. It also includes analysis into the observations of device products for the past five years including trend observations and a breakdown of the most common observations.
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5 Year Summary of FDA Drug 483s: 2015-2019 (single user digital version)
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 the past five years.
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5 Year Summary of FDA Biologics 483s: 2015-2019 (single user digital version)
This booklet takes the publicly available yearly inspection data from the U.S. FDA and presents it in a more useful, digestible format. It also includes analysis into the observations of biologics products for the past five years including trend observations and a breakdown of the most common observations.
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Managing the Pharmaceutical Cold Chain (single user digital version)
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 reference.
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Toward an Integrated Cold Chain (single user digital version)
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 reference. -
Serialisation Regulations in the EU and USA (single user digital version)
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 reference. -
Key Features of a Biosafety Program for the Biopharmaceutical Industry (single user digital version)
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 contamination control programs.
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