Publications
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Biological Indicators for Sterilization Processes (single user digital version)
This book will be of great interest to laboratory supervisors, regulatory and compliance personnel, validation specialists and professionals engaged in other aspects of pharmaceutical and biopharmaceutical manufacturing. -
PDA Technical Report No. 56 Revised 2016 (TR 56) Application of Phase-Appropriate Quality System and cGMP to the Development of Therapeutic Protein Drug Substance (API or Biological Active Substance) (single user digital version)
PDA Technical Report No. 56, Revised 2016 Application of Phase-Appropriate Quality System and cGMP to the Development of Therapeutic Protein Drug Substance provides an overview of the ideal state for broad good manufacturing practices (GMPs) throughout the product lifecycle and as they become more stringent from the discovery/R&D stage through Phase 3 clinical trials to commercial launch. -
Recent Warning Letters Review for Preparation of a Non-Sterile Processing Inspection, Volume 2 (single user digital version)
The focus of this book is to provide a way to prepare for an FDA inspection of a non-sterile facility by reviewing relevant Warning Letters recently issued. -
Lifecycle Risk Management for Healthcare Products: From Research Through Disposal (single user digital version)
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 create and maintain products that are at an acceptable level of safety for society through the product lifecycle. -
Recent Warning Letters Review for Preparation of an Aseptic Processing Inspection, Volume 1 (single user digital version)
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. This invaluable guide is a must read for all personnel involved in any way with the pharmaceutical aseptic processing inspection process. -
Lifecycle Risk Management for Healthcare Products: From Research Through Disposal (Hardcover)
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 create and maintain products that are at an acceptable level of safety for society through the product lifecycle. -
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)
This report provides a building block for developing a comprehensive specification for elastomeric components and aluminum seals. It offers consistent and standardized quality criteria that can be used by pharmaceutical and medical device manufacturers for the visual inspection of incoming elastomeric components and aluminum seals, and by suppliers for outgoing inspection. -
PDA Survey: 2015 Aging Facilities (single user digital version)
PDA established an Aging Facility Task Force to focus on the identification and modernization of aging facilities, processes and analytics. -
Risk Assessment and Management for Healthcare Manufacturing: Practical Tips and Case Studies (single user digital version)
The book is divided into four sections that present a formal approach to risk. Sections focus on risk assessment and hazards; common risk assessment tools and problem-solving approaches; 'soft skills' that help in conducting risk assessments; and case studies exploring the problems and events that occur with pharmaceuticals and healthcare, against which the reader can consider real-life problems. The wide range of topics covered includes risk considerations for aging pharmaceutical facilities, application of quality risk management to cleanroom design and process incident investigation. -
PDA Technical Report No. 75 (TR 75) Consensus Method for Rating 0.1μm Mycoplasma Reduction Filters (single user digital version)
This report educates users and filter manufacturers about best practices for mycoplasma reduction filtration and suggests the implementation of a specific filtration testing method and positive controls for establishing a manufacturer’s claims of mycoplasma reduction. -
Contamination Control in Healthcare Product Manufacturing, Volume 4 (single user digital version)
This text is an essential complement to a contamination control library as a useful reference guide when combined with the previous three volumes.
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Contamination Control in Healthcare Product Manufacturing, Volume 4 (Hardcover)
This text is an essential complement to a contamination control library as a useful reference guide when combined with the previous three volumes.
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Points to Consider for Aseptic Processing: Part 2, May 2016 (single user digital version)
The just-released Points to Consider for Aseptic Processing: Part 2 was created to address aseptic process simulation and validation, modern blow/fill/seal technology, RABS and isolators, cleaning, disinfection and sterilization and critical utilities. -
PDA Technical Report No. 74 (TR 74) Reprocessing of Biopharmaceuticals (single user digital version)
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 via recombinant and non-recombinant cell-culture expression systems.
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PDA Survey: 2015 Particulate Matter in Difficult to Inspect Parenterals (single user digital version)
This survey summarizes current practices in the inspection and control of particles in DIP products and packaging materials. Findings include aspects of current processes in manual, semi-automated and automated inspection, along with sampling plans and acceptable quantity limits (AQL) used. -
Pharmaceutical Legislation of the European Union, Japan and the United States of America - An Overview, Updated and Expanded Second Edition (single user digital version)
The book presents a condensed overview of the regulatory systems and processes for marketing a drug product in the three major global regions: Japan, the United States and the European Union. -
Assuring Data Integrity for Life Sciences (single user digital version)
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. -
PDA Survey: 2015 Particulate Matter in Oral Dosage Forms (single user digital version)
In August of 2014, the fourth survey in a series of surveys was launched by PDA to better understand and document current industry practices in this important area. Past PDA Visual Inspection surveys in 1996, 2003 and 2008 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. -
Visual Inspection and Particulate Control (single user digital version)
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 seasoned inspectors with the principles of microscopy and seasoned microscopists with the elements of visual inspection, this book describes ways to find visible defects and what to do with them once found.
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Global Sterile Manufacturing Regulatory Guidance Comparison (single user digital version)
The publication Global Sterile Manufacturing Regulatory Guidance Comparison – With link to Comparison Spreadsheet compares regulatory guidance documents issued by the U.S. FDA, the EU, the Pharmaceutical Inspection Convention/Scheme and the World Health Organization.
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