Publications
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Technical Report No. 68 (Revised 2024): Risk-Based Approach for Prevention and Management of Drug Shortages
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 to the current regulatory environment, regional regulations and guidelines, and terminologies used for drug shortages that have since been published. Elements in the templates and forms included in this revision have been updated to reflect current regulatory expectations and terminology. Drug shortages have become more frequent, more severe, and longer-lasting globally since the early 2000s for a variety of reasons. Sustainable access to safe, efficacious, and high-quality products every time a patient needs them is just as important as the therapeutic advances that have transformed the lives and survival of patients worldwide.
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Industrial Pharmaceutical Microbiology Quality Control
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 science, principles, development, intended purpose, and specific answers to questions of execution and qualification of compendial and related microbiological test methods. Key topics include the types of microbiological tests, reference strains and culture collections, and equivalence of reference strain.
Test methods and subject matter include bioburden, microbial enumeration, specified and objectionable microorganisms, antimicrobial effectiveness testing, endotoxins and sterility tests, microbial identification, biological indicators, water activity, disinfectant efficacy, and water. It also covers a critical, stimulating look into the topic of Environmental Monitoring. The comprehensive content provides useful guidance on the management of laboratory practices and laboratory assessments of processes and tasks. Emphasis is placed on a correct, contemporary, and standard of terminologies and definitions which is critical in the execution of these tests and a necessary common language when exploring their principles, development, execution, and troubleshooting.
In summary, Industrial Pharmaceutical Microbiology: Quality Control with its 20 chapters, 19 international authors and over 500 pages,enables the practitioner to have a complete understanding of these microbiological methods, and to ensure better developed, compliant, appropriate procedures and accurate meaningful data.
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Technical Report No. 73-2: Application of Medical Device Regulation Annex 1 Requirements for Staked Needle Syringes
PDA Technical Report No. 73-2: Application of Medical Device Regulations, Annex I Requirements for Staked Needle Syringes is an addendum to PDA TR-73 and provides recommendations on preparing the required documentation of the device part of the PFS to facilitate obtaining an NB opinion.
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Points to Consider No.9 Lessons Learned from the COVID-19 Pandemic
Points to Consider No.9: Lessons Learned from the COVID-19 Pandemic was started during the height of the pandemic. It captures ideas and learnings that were considered important to the pharmaceutical manufacturing industry during a tumultuous period when industry and regulators were looking for, and struggling with, how to move forward. Unlike many of our purely technical documents, this PtC captures a wide variety of topic areas and touches on points normally outside of PDA's normal pureview, such as human resources, public policy, and employee transportation. The intent was to provide a document that could be used to prepare for and respond to a similar pandemic if one was to occur in the future. While this document is not intended to cover all possible topics, it assists in ensuring that the industry does not forget the major learnings.
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Points to Consider No.1 Aseptic Processing (Revised 2023)
Points to Consider No.1 Aseptic Processing (Revised 2023) reflects current industry best practices and scientific positions as well as regulatory expectations. While the current revision maintains the original organization of topic into categories, topics that had been discussed separately in Parts 1 and 2 have been combined into a single document. Each topic discussion begins with a problem statement in the form of a question about issues or points needing clarification on that specific topic. Recommendations from the PDA task force are then presented as an answer to the question. The rationale and references for each recommendation follow.
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Technical Report No. 91 Post-Approval Change Management
43567 PDA Technical Report No. 91 Post-Approval Change Management and Implementation for Biologics and Pharmaceutical Drug Products — A User’s Guide
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Industrial Pharmaceutical Microbiology Standards & Controls 6th Edition
Industrial Pharmaceutical Microbiology: Standards and Control covers the entire spectrum of industrial pharmaceutical microbiology, as applicable to pharmaceuticals and healthcare. Connect instantly with regulations and current best practices on everything from disinfectants to sterility testing; environmental monitoring to hazard analysis; and from pharmaceutical processes to biological indicators. All of this is developed from an international perspective, where different regulations are compared and contrasted together with insightful commentary as to best practices. The new 6th edition of Industrial Pharmaceutical Microbiology: Standards and Controls provides clear, practical and up-to-date guidance for handling virtually every compliance and operational challenge associated with pharmaceutical microbiology.
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Technical Report No. 43 (Revised 2023): Identification and Classification of Nonconformities in Moulded and Tubular Glass Containers for Pharmaceutical Manufacturing
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 of visual nonconformities for glass containers. This second revision was issued to address evolving standards and container types.
The standardized quality criteria in TR 43 are intended as guidance for container manufacturers and for incoming container acceptance inspection at pharmaceutical companies. Five detailed lexicons have been updated which visually illustrate glass nonconformities, and defects specific to ready-to-use containers and their categorization are included for use as applicable. -
PDA Research: 2023 PDA Visual Inspection Survey (single user digital version)
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 in this field. The purpose of this survey was to document current industry practice for visual inspection of injectable products. Preliminary results from this survey were originally presented at the 2023 PDA Visual Inspection Forum held 17-18 April 2023 in Baltimore, MD. -
Technical Report No. 90: Contamination Control Strategy Development
This technical report addresses the ongoing evolution of contamination control principles to a holistic approach, where the practices are designed to work together to achieve proactive contamination control and are evaluated for their collective effectiveness. The holistic approach also demands that contamination control measures be tailored to the specific risks around each individual process. This document focuses on contamination control practices against microbial and other adventitious agents, endotoxins, and foreign particulate matter in the manufacture of sterile drugs, low bioburden drug substances, and some nonsterile drugs that are vulnerable to contamination. (single user digital version) -
Technical Report No. 89: Strategies for Vaccine Development
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 both prophylactic and therapeutic vaccines, for which “real world” examples are provided. Strategies are included that can be applied in early development to licensure as well as those that are focused on lifecycle management of marketed products.(single user digital version) -
PDA Research: 2021 PDA Aseptic Processing Simulation Survey (Single user digital version)
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 covering topics related to APS Concepts and Principles, APS Test Methods and Materials, Documentation, Environmental Monitoring, Interventions, Operator Qualification, and Acceptance Criteria. -
Points to Consider for Microbial Control in ATMP Manufacturing (Single user digital version)
This Points-to-Consider document provides a summary of microbiological challenges for ATMPs and guidance on how to address these challenges based on the current state of technology, regulatory environment, and industry best practices. It addresses ATMP process technologies from cell-free production of mRNA therapeutics to viral vector-induced in-vivo gene therapies to ex-vivo engineering of human cells for autologous or allogeneic cell therapies. The control aspects covered include facility design, equipment and instrumentation design and maintenance, analyst and operator gowning and qualification, and microbiological process monitoring.
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Technical Report No.41 Revised 2022 (TR 41): Virus Filtration
Technical Report No. 41 (Revised): Virus Retentive Filtration, provides a summary of best practices for utilization of virus filtration in process development and manufacturing. It explains what virus filters are and where they can be used in current and emerging bioprocesses. Recommendations for selection of a suitable virus filter are presented, and strategies for evaluating and validating virus retention by virus filtration are discussed. TR 41 also includes considerations that reflect best practices and current thinking for implementing virus filtration into novel manufacturing technologies.
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PDA Technical Report No.65 Revised 2022 (TR 65) Technology Transfer (Single user digital version)
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 technical transfer activities that help achieve operational readiness and culminate in regulatory approval. Designed to assist companies in the technology transfer process, this technical report covers the full range of requirements needed, such as new product introductions and the transfer of products that are being manufactured for phase III clinical trials or commercial release.
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Points to Consider in Remote and Hybrid GMP/GDP Audits (single user digital version)
This Points to Consider document describes steps that can be taken to ensure an effective and efficient remote assessment, focusing on aspects in a remote setting that are different from those in on-site audits. Standard nomenclature is introduced to describe the types of remote audits, and key considerations for their scheduling, duration, planning, conduct, closing, reporting, and follow up are presented. This document will help both the auditor and auditee facilitate effective and efficient remote audits. -
PDA Technical Report No. 13 Revised 2022 (TR 13) Fundamentals of an Environmental Monitoring Program (single user digital version)
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 (RMM). It will aid in the establishment of a robust environmental monitoring program that embraces innovation and the principles of quality risk management. Updates regarding microbiological and total airborne particulate control concepts and principles related to facilities involved in the manufacture of sterile pharmaceutical products are also included.
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PQRI: Safety Thresholds and Best Demonstrated Practices for Extractables and Leachables in Parenteral Drug Products (Intravenous, Subcutaneous, and Intramuscular)
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).
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ANSI/PDA Standard 02-2021: Cryopreservation of Cells for Use in Cell Therapies, Gene Therapies, and Regenerative Medicine Manufacturing (single user digital version)
This new standard provides guidance on how to establish suitable procedures for the cryopreservation and recovery of biological cells for use in cell and gene therapy products and regenerative medicine manufacturing either as an intermediate step or when cryopreservation is the final step. The guide emphasizes the effect cryopreservation and recovery may have on cell viability and cell function and can provide general guidance during the assessment of regulatory requirements. The best practices and guidance details outlined in the document provide general procedural support for cryopreservation of cell-based products during both early and late phases of product development.
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PDA Technical Report No. 88 (TR 88) Microbial Data Deviation Investigations in the Pharmaceutical Industry (single user digital version)
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. Distinct areas where microbial data is collected and inspected for deviation investigations are the focus of this document; the roles of other contributors to deviation investigations required for effective root cause analysis are also briefly described. This TR promotes a lifecycle approach, with an emphasis on laboratory and manufacturing investigations of marketed drug products.
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