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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 … -
Technical Report No. 68 (Revised 2024): Risk-Based Approach for Prevention and Management of Drug Shortages
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PDA Technical Report No. 68: Risk-Based Approach for Prevention and Management of Drug Shortages was originally developed in 2014. The approach to risk-based prevention of drug shortages presented in this revision remains unchanged. This revision focuses on updating references and progress related … -
Points to Consider No.9 Lessons Learned from the COVID-19 Pandemic
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As a result of the COVID-19 pandemic, many industries-the pharmaceutical included-went through a substantial disruption.Some of these disruptions included facility shutdowns, unprecedented supply chain challanges, worker availabitlity, and quality system limitations (e.g. physical signatures, … -
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 … -
PDA Research: 2021 PDA Aseptic Processing Simulation Survey (Single user digital version)
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The 2021 PDA Aseptic Process Simulation for Sterile Bulk Pharmaceuticals Survey was designed to provide insight on current industry practices of the aseptic process simulation (APS) used in the production of aseptically produced sterile bulk pharmaceuticals. There were 42 respondents with the survey … -
Technical Report No.41 Revised 2022 (TR 41): Virus Filtration
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Technical Report No. 41 (Revised): Virus Retentive Filtration, provides a summary of best practices for utilization of virus filtration in process development and manufacturing. The document explains what virus filters are and where they can be used in current and emerging bioprocesses. Recommendations … -
PDA Technical Report No.65 Revised 2022 (TR 65) Technology Transfer (Single user digital version)
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This technical report aims to provide a standardized approach to the technology transfer process. It supplies a matrixed "Reference Guide to Technology Transfer Activities and Deliverables," which can be used to coordinate cross-functional technology transfer activities that help achieve operational … -
PDA Technical Report No. 13 Revised 2022 (TR 13) Fundamentals of an Environmental Monitoring Program (single user digital version)
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This revision of TR 13 aligns with current industry trends and regulatory expectations and provides additional guidance and focus on increased expectations concerning data management and data integrity, qualification and maintenance of controlled environments, and rapid microbiological methods … -
ANSI/PDA Standard 02-2021: Cryopreservation of Cells for Use in Cell Therapies, Gene Therapies, and Regenerative Medicine Manufacturing (single user digital version)
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ANSI/PDA Standard 02-2021: Cryopreservation of Cells for Use in Cell Therapies, Gene Therapies, and Regenerative Medicine Manufacturing: An Introduction and Best Practices Approach on How to Prepare, Cryopreserve, and Recover Cells, Cell Lines, and Cell-Based Tissue ProductsThis new standard provides … -
PDA Technical Report No. 88 (TR 88) Microbial Data Deviation Investigations in the Pharmaceutical Industry (single user digital version)
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This technical report presents a holistic approach for performing a microbiological investigation. It provides a framework to assist with focusing on the investigational areas that may contain or contribute to the root cause of data deviations, such as sampling, test methodology, and suitability of the … -
PDA Technical Report No. 39 Revised 2021 (TR 39) Guidance for Temperature-Controlled Medicinal Products - Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment (single user digital version)
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This technical report provides guidance for establishing a quality management system for distribution of all types of temperature-sensitive medicinal and pharmaceutical products. This guidance covers the shipping site, where the product is prepared for transportation, and the shipment of the … -
PDA Technical Report No. 87 (TR 87) Current Best Practices for Pharmaceutical Glass Vial Handling and Processing (single user digital version)
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This technical report focuses on a technical understanding of glass, its strength, and its limitations, and provides guidance in best handling practices for glass vials throughout the pharmaceutical process — receipt, storage, preparation, filling, stoppering, freeze-drying, and capping. This document … -
ANSI/PDA Standard 05-2021: Consensus Method for Rating Filters for Mycoplasma Reduction (single user digital version)
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This new standard describes a filter challenge test for standardizing test parameters across laboratories using 47 mm discs and using A. laidlawii as the test organism. While this standard is primarily to educate users and filter manufacturers about best practices for mycoplasma reduction … -
PDA Technical Report No. 86 (TR 86) Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing (single user digital version)
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This technical report is a consensus-based resource surrounding the challenges encountered in using complex package systems and introduces important elements to consider in decision-making. It also offers an examination of the technologies available for package integrity testing not yet established by … -
PDA Technical Report No. 85 (TR 85) Enhanced Test Methods for Visible Particle Detection and Enumeration on Elastomeric Closures and Glass Containers (single user digital version)
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Visual inspection of filled injectable products is an important part of the control strategy of the manufacturing process. It offers a means to improve quality by removing noncompliant units and provides information to drive continuous process improvement. This technical report addresses test and inspection … -
PDA Research: 2020 Particulate Matter in Flexible Containers Survey (single user digital version)
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The 2020 PDA Research Particulate Matter in Flexible Containers Survey was undertaken to address the industry-wide concern raised by multiple recalls for particulate matter in flexible container and other container products dating back to 2012.This survey was conducted to establish a benchmark of current … -
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 …
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