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Technical Report No. 82: Low Endotoxin Recovery
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This Technical Report aims to describe the underlying mechanisms and contributing factors of LER, summarize the potential clinical impact of the LER phenomenon, present guidelines for developing LER hold-time study design, and provide strategies for the mitigation of LER. Available to download. Prior … -
SOPs Clear and Simple: For Healthcare Manufacturers (single user digital version)
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There are four simple sentences that define the concept of compliance and its relationship to Standard Operating Procedures (SOPs) — Say what you do. Do what you say. Prove it. Improve it. Despite this concept seeming simple, the number one topic of 483 observations for biologics, drugs, and devices … -
Technical Report No. 81: Cell-Based Therapy Control Strategy
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This TR focuses on the development of a risk-based control strategy adapted to cell-based therapy that can mitigate the risk of generating a product of poor quality. Available to download. Prior to purchase please view the download instructions and Terms of Usage. Format: PDF (1 file 3.45 MB) Click … -
Cleaning SOPs: Five Proven and Validated SOPs (single user digital version)
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Cleaning and sanitization is a common 483 citing. The cleaning methods in these five SOPs have been proven and validated. They are based upon published information in US standards and ISO standards. Renowned global expert, Anne Marie Dixon-Heathman offers you invaluable details that will assist you … -
Biopharmaceutical Validation and Technical Transfer (single user digital version)
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This document discusses why and how to validate and transfer a process. It offers a helpful example, includes protocol details and discusses non-traditional process validation, life cycle management, change management and much more. Available to download. Prior to purchase please view the download … -
Contamination Control in Healthcare Product Manufacturing, Volume 5 (single user digital version)
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The fifth volume to PDA's popular series, Contamination Control in Healthcare Product Manufacturing, explores practical approaches to leverage environmental monitoring data to improve performance, how to design a risk-based environmental monitoring program for non-sterile manufacturing, the clinical … -
Technical Report No. 80: Data Integrity Management System for Pharmaceutical Laboratories
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This Technical Report, developed by subject matter experts from the global pharmaceutical industry and regulatory agencies, provides the framework and tools necessary to establish a robust data integrity management system to ensure data integrity for paper, hybrid, and computerized systems within the … -
GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry, Fifth Edition, Revised & Expanded (single user digital version)
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The Long-Awaited Revision and Update of GMP in Practice is Here! Have you ever asked yourself, "Where in the Good Manufacturing Practices (GMPs) does it say I have to do _______?" If so, look no further than PDA's GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry, fifth … -
Microbial Control and Identification: Strategies Methods Applications (single user digital version)
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In PDA's latest release, expert microbiologists and biopharmaceutical industry leaders explore the role of microbial identification knowledge as a cornerstone in the concept of microbial and contamination control programs. This book is an excellent reference for new microbiologists and seasoned professionals … -
Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volume 2 (single user digital version)
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Clearance Sale - 20% off! Original Price US$235 PDA Member, US$289 Nonmember, US$155 Government Sale prices are already displayed and will be reflected during checkoutThe first edition of Microbiology in Pharmaceutical Manufacturing, published in 2001, is THE best selling PDA/DHI book of all time. … -
Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volume 1 (single user digital version)
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Clearance Sale - 20% off! Original Price US$235 PDA Member, US$289 Nonmember, US$155 Government Sale prices are already displayed and will be reflected during checkoutThe first edition of Microbiology in Pharmaceutical Manufacturing, published in 2001, is THE best selling PDA/DHI book of all time. … -
PDA Research: 2017 PDA Glass Quality Survey (single user digital version)
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The 2017 PDA Glass Quality Survey is designed to assist in the identification of glass container quality concerns and development of solutions to overcoming them. Survey topics include glass sampling and inspection practices, product complaints and recalls due to glass defects, and quality … -
Technical Report No. 79: Particulate Matter Control in Difficult to Inspect Parenterals
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PDA Technical Report No. 79, Particulate Matter Control in Difficult to Inspect Parenterals describes best practices for difficult to inspect parenteral (DIP) product lifecycle management, destructive testing, and trending to supplement portions of the guidance given in USP General … -
PDA Technical Series: Pharmaceutical Glass
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The PDA Technical Series: Pharmaceutical Glass is a collection of articles previously published in the PDA Journal of Pharmaceutical Science and Technology . This compilation organizes 19 articles on glass published between 2007 and 2017 into four categories: Overview, Material … -
Risk Management Library Volume 7, Risk Problem Solvers: Inadequate Facilities, Procedures and Process Control (single user digital version)
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Pharmaceutical and Biopharmaceutical Manufacturing: Understanding Your Process Series The U.S. FDA plans to take a risk-based approach to biomanufacturing inspection and changes are expected very soon. With regulatory expectations and the impending changes anticipated in 21CFR 600 in June 2018, now is … -
Risk Management Library Volume 6, Risk Problem Solvers: Lack of Process Understanding (single user digital version)
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Pharmaceutical and Biopharmaceutical Manufacturing: Understanding Your Process Series The U.S. FDA plans to take a risk-based approach to biomanufacturing inspection and changes are expected very soon. With regulatory expectations and the impending changes anticipated in 21CFR 600 in June 2018, now is … -
Risk Management Library Volume 5, Risk Problem Solvers: Failure to Follow Established Procedures (single user digital version)
PDF Single user
Pharmaceutical and Biopharmaceutical Manufacturing: Understanding Your Process Series The U.S. FDA plans to take a risk-based approach to biomanufacturing inspection and changes are expected very soon. With regulatory expectations and the impending changes anticipated in 21CFR 600 in June 2018, now is … -
Risk Management Library Volume 4: Practical Approaches to Risk Assessment and Management Problem Solving: Tips and Case Studies (single user digital version)
PDF Single user
Pharmaceutical and Biopharmaceutical Manufacturing: Understanding Your Process Series The U.S. FDA plans to take a risk-based approach to biomanufacturing inspection and changes are expected very soon. With regulatory expectations and the impending changes anticipated in 21CFR 600 in June 2018, now is … -
Risk Management Library Volume 3: Practical Approaches to Risk Assessment and Management (single user digital version)
PDF Single user
Pharmaceutical and Biopharmaceutical Manufacturing: Understanding Your Process Series The U.S. FDA plans to take a risk-based approach to biomanufacturing inspection and changes are expected very soon. With regulatory expectations and the impending changes anticipated in 21CFR 600 in June 2018, now is … -
Risk Management Library Volume 2: Practical Approaches to Risk-Based Compliance (single user digital version)
PDF Single user
Pharmaceutical and Biopharmaceutical Manufacturing: Understanding Your Process Series The U.S. FDA plans to take a risk-based approach to biomanufacturing inspection and changes are expected very soon. With regulatory expectations and the impending changes anticipated in 21CFR 600 in June 2018, now is …
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