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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 … -
GMP Validation: A Guide to International Regulatory Requirements
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Within the pharmaceutical and healthcare sector, validation and qualification form an important part of the quality system. However, understanding the differences between different regulatory agencies and the recommendations of different standards can be a bewildering project. This book seeks to … -
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 … -
Industrial Pharmaceutical Microbiology Quality Control
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An in-depth comprehensive survey of QC pharma methods in the microbiology laboratory to enable a better understanding of these methods, and to ensure better developed, more compliant, expedited procedures.The reference text brings together the hitherto unavailable background, fundamental … -
Technical Report No. 73-2: Application of Medical Device Regulation Annex 1 Requirements for Staked Needle Syringes
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PDA Technical Report No. 73-2: Application of Medical Device Regulations, Annex I Requirements for Staked Needle Syringes represents the current state of knowledge as to the application of European Union Regulation (EU) 2017/745 on medical devices (MDR).Since this regulatory requirement is new, expectations … -
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. 91 Post-Approval Change Management
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This technical report expands on the latest concepts and tools for improving PAC management, as published in ICH Q12. It provides a practical guide for the pharmaceutical industry on how to implement PACs within the framework of an effective pharmaceutical quality system (PQS) and in alignment with … -
Industrial Pharmaceutical Microbiology Standards & Controls 6th Edition
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The contamination control of pharmaceutical and healthcare environments and processes, together with pre-clinical drug development labs, requires a far more holistic approach than simply choosing technologies and disinfectants. Today the microbiologist is expected to understand industrial processes … -
Technical Report No. 43 (Revised 2023): Identification and Classification of Nonconformities in Moulded and Tubular Glass Containers for Pharmaceutical Manufacturing
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PDA Technical Report No. 43 (Revised 2023): Identification and Classification of Nonconformities in Moulded and Tubular Glass Containers for Pharmaceutical Manufacturing provides an approach to a quality decision-making process and represents best practices for the identification and classification … -
PDA Research: 2023 PDA Visual Inspection Survey (single user digital version)
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From November 2022 through January 2023, the fifth survey in a series of surveys on visual inspection was conducted by PDA to better understand current industry practices in this important area. Past surveys in 1996, 2003, 2008, and 2014 have provided practical guidance and insight to those working … -
Points to Consider for Microbial Control in ATMP Manufacturing (Single user digital version)
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Since health authorities have not yet published guidelines for a comprehensive control strategy specific to microbiological topics for ATMPs, it is up to the individual ATMP sponsor or license holder to apply these compendial references properly. This Points-to-Consider document provides a summary of … -
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 … -
Points to Consider in Remote and Hybrid GMP/GDP Audits (single user digital version)
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This Points to Consider document describes steps that can be taken to ensure an effective and efficient remote assessment. It introduces standard nomenclature to describe the types of remote audits and discusses key considerations for their scheduling, duration, planning, conduct, closing, … -
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 … -
PQRI: Safety Thresholds and Best Demonstrated Practices for Extractables and Leachables in Parenteral Drug Products (Intravenous, Subcutaneous, and Intramuscular)
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The Product Quality Research Institute (PQRI) Leachables and Extractables (L&E) Working Group provided recommendations to the US Food and Drug Administration in 2006 on safety thresholds and best demonstrated practices for orally inhaled and nasal drug products (OINDP). The published PQRI E&L … -
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 …
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