Publications
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Overview of Conventional and Emerging Microbial Identification Methods (single user digital version)
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 contamination control programs.
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Quality Control Testing Throughout the Product Development Lifecycle (single user digital version)
The magnitude of knowledge and experience required to have a meaningful impact on biotechnology product approvals and market success is monumental. For the first time, expertly crafted chapter is reprinted from Biotechnology From Idea to Market, edited by Fred Mermelstein, Richard Prince and Carl Novina and offered electronically. These detailed advisories are written to provide guidance. -
Manufacturing Biopharmaceuticals From Start-Up to Commercialization (single user digital version)
The magnitude of knowledge and experience required to have a meaningful impact on biotechnology product approvals and market success is monumental. For the first time, expertly crafted chapter is reprinted from Biotechnology From Idea to Market, edited by Fred Mermelstein, Richard Prince and Carl Novina and offered electronically. These detailed advisories are written to provide guidance.
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Quality Risk Management in the Context of Viral Contamination (single user digital version)
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 contamination control programs.
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Regulatory Affairs Role in Product Development
The magnitude of knowledge and experience required to have a meaningful impact on biotechnology product approvals and market success is monumental. For the first time, expertly crafted chapter is reprinted from Biotechnology From Idea to Market, edited by Fred Mermelstein, Richard Prince and Carl Novina and offered electronically. These detailed advisories are written to provide guidance. -
Lessons of Failure library
Russell Madsen and Maik Jornitz have assembled and edited fascinating stories of incidents from their own experiences and those of other long serving industry practitioners and experts. Reprinted from their text: Lessons of Failure: When Things Go Wrong in Pharmaceutical Manufacturing, these vignettes offer both what can go wrong and key problem-solving points to take away and apply. -
FDA Warning Letters: Analysis and Guidance (single user digital version)
The best way to handle Warning Letters issued by the U.S. FDA is to prevent them. This text identifies and discusses those Letters recently issued, offers analysis, and provides guidance to help readers avoid receiving such a letter. -
FDA Warning Letters: Analysis and Guidance (Hardcover)
The best way to handle Warning Letters issued by the U.S. FDA is to prevent them. This text identifies and discusses those Letters recently issued, offers analysis, and provides guidance to help readers avoid receiving such a letter.
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PDA Research: 2019 PDA Traceability of Primary Packaging Survey (single user digital version)
Serialization in the pharmaceutical supply chain is a growing effort to improve shortcomings within the current track and trace processes. The survey will help PDA members, industry, and regulators understand the current state of demand and issues surrounding track and trace and attain additional insight to the discussions that may be occurring at the site level to improve controls and traceability of drug product from production to the patient. -
PDA Technical Report No. 54-6 (TR 54-6) Formalized Risk Assessment for Excipients (single user digital version)
PDA Technical Report No. 54-6, Risk Assessment for Excipients, is the sixth technical report (TR) in the TR 54 series related to various aspects of Quality Risk Management (QRM). It was developed to provide additional guidance on the excipient risk assessment process required by the European Commission Guidelines on the formalized risk assessment for ascertaining the appropriate GMP for excipients of medicinal products for human use and incorporated into the PIC/S publication of the same name. The information in TR 54-6 applies to all excipients used in drug products for human use at all stages of the product lifecycle. -
Fungi: A Handbook for Life Science Manufacturers and Researchers (Hardcover)
This text can help identify and ameliorate fungal and mold problems and contains a wealth of information as a guide and reference. Many topics are discussed relevant to the food and agriculture industries, including the biology of fungi, outbreaks associated with pharmaceutical drug products and medical devices, mycotoxins, fungal biodegradation and remediation, and strategies for a rapid and accurate fungal identification. The text also contains a lengthy fungal glossary. -
Fungi: A Handbook for Life Science Manufacturers and Researchers (single user digital version)
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Risk-Based Software Validation (Single user digital version)
This book offers a systematic, 10-step approach, from the decision to validate to the assessment of the validation outcome, for validating configurable off-the-shelf computer software that generates data or controls information about products and processes subject to binding regulations
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PDA Research: 2019 Sterile Lyophilized Drug Product Loading Survey (single user digital version)
This survey is designed to align and expand PDA's insight on current practices for companies that manufacture sterile lyophilized drug products and conduct lyophilizer loading. It also provides insight into how today's lyophilizer loading area operations can be improved to reduce contamination from personnel. Each of the 91 respondents is involved in lyophilizer activities within their current companies and possess an understanding of their companies' procedures and needs. -
Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers, Volume 2 (single user digital version)
Following an introduction to the subject of Good Distribution Practice (GDP), in the second volume, dive into supply-chain risk mitigation, serialization, and packaging as it relates to risk assessments. This text and its companion Volume 1 will help drive down costs and improve efficiency.
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Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers, Volume 2 (Hardcover)
Following an introduction to the subject of Good Distribution Practice (GDP), in the second volume, dive into supply-chain risk mitigation, serialization, and packaging as it relates to risk assessments. This text and its companion Volume 1 will help drive down costs and improve efficiency.
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Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers, Volume 1 (single user digital version)
Following an introduction to the subject of Good Distribution Practice (GDP), the first volume of this book covers key topics related to five main points: the applicable GDP regulations worldwide, including serialization; an overview of the requirements of Qualified Persons and Responsible Persons in GDP; GDP as part of the Quality Management System; an industry perspective on GDP; and a practical GDP checklist. This text and its companion Volume 2 will help drive down costs and improve efficiency. -
Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers, Volume 1 (Hardcover)
Following an introduction to the subject of Good Distribution Practice (GDP), the first volume of this book covers key topics related to five main points: the applicable GDP regulations worldwide, including serialization; an overview of the requirements of Qualified Persons and Responsible Persons in GDP; GDP as part of the Quality Management System; an industry perspective on GDP; and a practical GDP checklist. This text and its companion Volume 2 will help drive down costs and improve efficiency. -
PDA Technical Report No. 83 (TR 83) Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness, and Response (single user digital version)
The purpose of this technical report is to describe the proven, successful principles used and measures that can be taken to mitigate the risk of contamination by viruses and to provide guidance in effective preparation and response should such an event occur in manufacturing processes using in vitro mammalian or other eukaryotic cell cultures to produce biopharmaceutical products.
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PDA Research: 2019 Technology Transfer Industry Survey (single user digital version)
PDA has just released the 2019 Technology Transfer Industry Survey, designed to investigate current practices and learn how companies conduct technology transfers, including their technology transfer processes, knowledge and risk management systems, documentation, and business strategies.
More than 250 industry professionals from around the world completed the survey. Respondents are experts involved in technology transfer activities within their current companies who possess a strong understanding of their companies’ technology transfer procedures and/or activities.
This survey report assesses, across a wide range of entities, the types of technology transfers being performed, the tools and processes used in those transfers, the use of multidisciplinary teams, the potential regulatory complications, and the impact of emerging technologies.
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