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Lifecycle Risk Management for Healthcare Products: From Research Through Disposal (single user digital version)
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This book provides current information on the risk management process as it applies to health and safety of health products, drugs and biologics, medical devices and products that are a combination of two or more of these. The application of the processes will help manufacturers of these products to … -
Recent Warning Letters Review for Preparation of an Aseptic Processing Inspection, Volume 1 (single user digital version)
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The focus of this book is to provide a way to prepare for a FDA inspection of an aseptic facility by reviewing Warning Letters recently issued to pharmaceutical companies. The number of Warning Letters issued by FDA has been rising in recent years. The FDA publishes Warning Letters in its Electronic … -
PDA Technical Report No. 76 (TR 76) Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging (single user digital version)
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PDA's newly released Technical Report No. 76 (TR 76) Identification and Classification of Nonconformities in Elastomeric Closures and Aluminum Seals for Parenteral Packaging provides a building block for developing a comprehensive specification for elastomeric components and aluminum seals. It offers … -
PDA Survey: 2015 Aging Facilities (single user digital version)
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Aging facilities contribute to a variety of challenges in pharmaceutical manufacturing, including drug shortages and product recalls. In response to calls for support in this area from industry and regulators, PDA established an Aging Facility Task Force to focus on the identification and modernization … -
Risk Assessment and Management for Healthcare Manufacturing: Practical Tips and Case Studies (single user digital version)
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Avoidance of hazards and assessment of risk have long been part of the manufacture of pharmaceuticals and healthcare products. A high quality drug product must be free from contamination and reliably deliver the intended therapeutic dose as stated on the label and to achieve this manufactures must always … -
PDA Technical Report No. 75 (TR 75) Consensus Method for Rating 0.1μm Mycoplasma Reduction Filters (single user digital version)
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PDA's newly released Technical Report No. 75 (TR 75) Consensus Method for Rating 0.1µm Mycoplasma Reduction Filters describes a consensus filter challenge test for standardizing test parameters across laboratories. This report educates users and filter manufacturers about best practices for mycoplasma … -
Contamination Control in Healthcare Product Manufacturing, Volume 4 (single user digital version)
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Edited by experts and written by global subject matter professionals, this vital addition to the Contamination Control series offers new chapters covering current, relevant information including:Regulatory changes relative to ISO 14644, Parts 1 and 2 Updates to ISO 11737-1 Risks of spores including preventive … -
Contamination Control in Healthcare Product Manufacturing, Volume 4 (Hardcover)
Book
Edited by experts and written by global subject matter professionals, this vital addition to the Contamination Control series offers new chapters covering current, relevant information including:Regulatory changes relative to ISO 14644, Parts 1 and 2 Updates to ISO 11737-1 Risks of spores including preventive … -
PDA Technical Report No. 74 (TR 74) Reprocessing of Biopharmaceuticals (single user digital version)
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This technical report provides guidance in the design, development, controls, procedures, validation, regulatory submission and implementation of reprocessing procedures for biopharmaceutical manufacturing. It focuses on recombinant biopharmaceutical products, including proteins and polypeptides produced … -
PDA Survey: 2015 Particulate Matter in Difficult to Inspect Parenterals (single user digital version)
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Due to the lack of detailed guidance and best practices for inspection and particle control in difficult to inspect parenteral (DIP) products, PDA has established a technical report team to address particulate matter in difficult to inspect parenterals. As a first step in developing a better understanding … -
Pharmaceutical Legislation of the European Union, Japan and the United States of America - An Overview, Updated and Expanded Second Edition (single user digital version)
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Whether you are a student, a newcomer to the pharmaceutical industry or a seasoned professional, the second edition of this book has something for everyone. The book presents a condensed overview of the regulatory systems and processes for marketing a drug product in the three major global regions: … -
Assuring Data Integrity for Life Sciences (single user digital version)
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This new book provides a truly global perspective on data integrity and the solutions available to address this serious issue. It includes two main sections: the regulatory and historic background of data integrity, and practical advice on how to prevent or rectify data integrity breaches.Each chapter … -
PDA Survey: 2015 Particulate Matter in Oral Dosage Forms (single user digital version)
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Particulate matter in oral dosage forms has been the subject of customer complaints, recalls and regulatory actions. However, there is currently no clear industry standard or guidance on mitigation, acceptance criteria, clinical relevance, inspection, sampling, testing or acceptable complaint levels … -
Visual Inspection and Particulate Control (single user digital version)
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This book is a practical guide for the control of visible defects and contamination in pharmaceutical products. It is intended for the product inspectors and lab support personnel, as well as those who use inspection results or are responsible for inspection operations. Meant to familiarize and educate … -
Why Life Science Manufacturers Do What They Do in Development, Formulation, Production and Quality: A History (single user digital version)
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Sale - 20% off!Original Price US$210 PDA Member, US$259 Nonmember, US$190 Government Sale prices are already displayed and will be reflected during checkoutIn a passionate retrospective of a successful career built on thinking statistically and applying that approach to quality in pharmaceutical … -
Lessons of Failure: When Things Go Wrong In Pharmaceutical Manufacturing (single user digital version)
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Russ Madsen and Maik Jornitz have assembled fascinating stories from renowned industry practitioners who share their global work experiences to highlight root cause analysis and problem solving. Each story is written as a brief lesson that begins with a statement of the problem, the steps taken to analyze … -
PDA Technical Report No. 73 (TR 73) Prefilled Syringe User Requirements for Biotechnology Applications (single user digital version)
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PDA Technical Report No. 73 (TR 73) Prefilled Syringe User Requirements for Biotechnology Applications discusses the requirements for the 1 mL long glass prefilled syringe (PFS) for biotechnology applications.Over the past decade, a large number of subcutaneously injected biotechnology drug products … -
PDA Survey: 2014 Visual Inspection (single user digital version)
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Visual inspection continues to be a critical step in the manufacture and release of high quality injectable medicines. There is limited specific guidance on inspection methods or acceptance criteria which has led to a wide range of industry practices. This diversity is also to be expected given the variety … -
PDA Technical Report No. 72 (TR 72) Passive Thermal Protection Systems for Global Distribution: Qualification and Operational Guidance (single user digital version)
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PDA Technical Report No. 72 (TR 72) Passive Thermal Protection Systems for Global Distribution: Qualification and Operational Guidance discusses the qualification and operational handling of passive thermal protection systems (TPS) for temperature-controlled distribution of pharmaceutical and biological … -
PDA Survey: 2014 Quality Culture Metrics (single user digital version)
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This publication presents the results of the PDA Quality Culture Metrics Surveys conducted in September and October 2014. Because similar questions were asked, two sets of results are shown side by side: those from the survey open to all PDA members and those from the survey sent to Heads of Quality …
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