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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 …

The 2021 PDA Post-Approval Change Issues and Impacts Survey provides experts' views on the most significant post-approval change issues faced by manufacturers of drug products (DPs) and active pharmaceutical ingredients (APIs). By understanding the challenges that industry faces in making manufacturing …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

**Winter Booksale: 25% OFF!**A standard guidance for the selection and control of suppliers of purchased goods and services that can impact product quality and patient …

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 …

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 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, …

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 …

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 …

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 …

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 …