Publications
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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)
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 product, from the product leaving the shipping site until its arrival at the receiving site where it will be stored or distributed to patient (end user). This Technical Report offers a resource for all involved stakeholders in the pharmaceutical supply chain, providing a model for qualifications from the process design through implementation and operation to verification.
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PDA Technical Report No. 87 (TR 87) Current Best Practices for Pharmaceutical Glass Vial Handling and Processing (single user digital version)
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. It also reviews typical pharmaceutical glass handling processes; identifies areas of concern; and presents points to consider, guidance, and practical approaches to improve processes. -
ANSI/PDA Standard 05-2021: Consensus Method for Rating Filters for Mycoplasma Reduction (single user digital version)
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 filtration, this test is also to be used by the filter manufacturers to validate a mycoplasma-retentive filter within a manufacturing process and to qualify a filter for a mycoplasma retentive claim. -
The Study in Risk-Based Manufacturing Environmental Control for Non-Sterile Drug Products (English Translation) (single user digital version)
The Kansai Study Group (KSG) of the PDA Japan Chapter (JPDA) published this paper based on a survey of JPDA member companies to offer consensus-based ideas to help pharmaceutical manufacturers establish appropriate, risk-based manufacturing and environmental control systems for quality non-sterile drug products. They determined the five most common themes: HVAC systems, facilities, gowning, cleaning, and cleanliness standards. For each of these themes, a problem is stated, recommendations are proposed, and a rationale is provided.
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Points to Consider in Remote and Hybrid GMP/GDP Inspections (single user digital version)
The new PDA Points to Consider in Remote and Hybrid GMP/GDP Inspections examines advantages and best practices for planning and implementing all types of remote regulatory inspections, including desktop, virtual, and hybrid inspections. It describes best practices that will help all participants engage efficiently and avoid unnecessary or unexpected delays, stressors, or complications in the remote inspection process. The suggestions in this document may be useful to sites that are the target of inspections and to health authorities.
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PDA Technical Report No. 86 (TR 86) Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing (single user digital version)
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 peer-reviewed research.
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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)
This technical report aims to provide clear technical guidance for the development and design of a process validation master plan using a risk-based lifecycle approach, and to provide a comprehensive overview of strategies that may be used to validate a manufacturing process or unit operations. -
PDA Research: 2020 Particulate Matter in Flexible Containers Survey (single user digital version)
This survey was conducted to establish a benchmark of current industry practices in the area of visual inspection of injectable products with emphasis on flexible container closure systems. It is intended to obtain more details specific to the role of visual inspection as it pertains to the wide variety of flexible container closure systems.
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Conducting Compliant Investigations (single user digital version)
In this book, edited by Jeanne Moldenhauer, 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 be instrumental in helping you to significantly reduce regulatory risk.
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The Infamous Fungus: Enigmatic, Distinct and Misjudged (single user digital version)
This chapter is taken from the book Fungi: A Handbook for Life Science Manufacturers and Researchers, edited by Jeanne Moldenhauer. This chapter explores all aspects of fungi and mold including their sources, structures, reproduction, as well as their use in every aspect of our lives.
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Quality by Design - An Indispensable Approach to Accelerate Biopharmaceutical Product Development (single user digital version)
PDA's book, Quality by Design — An Indispensable Approach to AccelerateBiopharmaceutical Product Development, is an important contribution to the ongoing dialogue for accelerating CMC product development bridging strategies for biotherapeutics and vaccines. It illustrates how Quality by Design (QbD) can be a powerful enabler of acceleration, fostering deeper understanding of what is critical, what level of CMC risk is acceptable, and hence what elements of product development can be streamlined. This book also demonstrates how Prior Knowledge is useful to inform QbD-driven risk assessment and focus on non-redundant activities, fostering tailored innovation. -
PDA Technical Report No. 60-3 (TR 60-3) Process Validation: A Lifecycle Approach, Annex 2: Biopharmaceutical Drug Substances Manufacturing (single user digital version)
This technical report aims to provide clear technical guidance for the development and design of a process validation master plan using a risk-based lifecycle approach, and to provide a comprehensive overview of strategies that may be used to validate a manufacturing process or unit operations. -
Cleanroom Contamination Prevention & Control: A Practical Guide to the Science (single user digital version)
This text covers risk-based approaches to a cleaning and disinfection program and case studies in contamination control. It provides details on safe building techniques for new cleanrooms and modifications of existing areas by providing a risk-based approach for cleaning and disinfection using good science. It also discusses the dangers of outdated cleanroom and barrier systems designs, and that limited understanding of the real airflows has led to repeat contamination related observations worldwide. Case study examinations discuss the most common causes of contamination and many useful solutions on how to proactively prevent recurring contamination are presented.
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ANSI/PDA Standard 04-2021: Phage Retention Nomenclature Rating for Small- and Large-Virus Retentive Filters (single user digital version)
This new standard addresses virus-removal filters that retain viruses by a size-exclusion mechanism. It is intended to provide filter suppliers with an approach to standardizing methodology and nomenclature for large- and small-virus retentive filters using bacteriophage as a model and to assist users/manufacturers in selecting the most appropriate filter for their specific application needs. -
PDA Research: 2021 Post-Approval Change Issues and Impacts Survey (single user digital version)
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 changes to products after the initial regulatory approval, regulators and industry together can develop effective solutions and prioritize the issues with greatest impact on global operations.
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Digital Transformation and Regulatory Considerations for Biopharmaceutical and Healthcare Manufacturers, Volume 2: Digital Data, Insights, Metrics and Analytics (single user digital version)
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 covers topics such as new model healthcare, office technology, e-learning, virtual inspections, and more.
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Digital Transformation and Regulatory Considerations for Biopharmaceutical and Healthcare Manufacturers, Volume 2: Digital Data, Insights, Metrics and Analytics (Hardcover)
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 covers topics such as new model healthcare, office technology, e-learning, virtual inspections, and more.
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Reporte Tecnico No. 1 (Revisado en 2007) Validacion de los Procesos de Esterilizacion por Calor Humedo: Diseno del Ciclo, Desarrollo, Calificacion y Control Continuo (versión digital de un solo usuario)
Este reporte técnico fue preparado por el task force constituido por 42 industrias Europeas y Norte Americanas así como profesionales en regulación para garantizar que los métodos, terminología y prácticas de la ciencia de esterilización presentados reflejan una ciencia sólida que pueda ser usada globalmente. Se difundió en borrador para revisión y comentarios públicos, previo a su publicación, proporcionando la revisión más amplia posible del documento para asegurar su idoneidad como una valiosa guía para la industria en esterilización por vapor. Esta organizado en una progresión lógica desde los elementos esenciales de la ciencia y la tecnología de la esterilización hasta el desarrollo y la calificación del ciclo de esterilización.
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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 (single user digital version)
This technical report is a complementary addendum to PDA Technical Report No. 13 (TR 13, Revised 2014) that provides elements to consider when designing a risk-based environmental monitoring program to support the manufacture of low bioburden products using low bioburden processes. A review of regulatory requirements and the development of risk assessments based on the criticality and complexity of processes is included, along with industry examples of these risk-based approaches.
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Digital Transformation and Regulatory Considerations for Biopharmaceutical and Healthcare Manufacturers, Volume 1: Digital Technologies for Automation and Process Improvement (single user digital version)
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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