PDA Technical Reports (TRs) offer expert guidance and opinions on important scientific and regulatory topics and are used as essential references by industry and regulatory authorities around the world. These resources are peer-reviewed, global consensus documents written by subject matter experts on issues relating to a wide array of challenging technical areas. PDA’s TR Library currently includes more than 80 invaluable and influential reports. New Releases PDA Technical Report 82 (TR 82), Low Endotoxin Recovery This TR describes the underlying mechanisms and contributing factors of low endotoxin recovery (LER), summarizes the potential clinical impact of the LER phenomenon, presents guidelines for developing LER hold-time study design, and provides strategies for the mitigation of LER. PDA Technical Report 81 (TR 81), Cell-Based Therapy Control Strategy This TR focuses on the development of a risk-based control strategy adapted to cell-based therapy that can mitigate the risks of generating a product of poor quality. PDA Technical Report 80 (TR 80), Data Integrity Management System for Pharmaceutical Laboratories Gain 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 laboratory. This TR outlines regulatory requirements and expectations and best industry practices to ensure data integrity, to highlight common gaps in laboratory data management practices, and to recommend methods of remediation. Best Sellers PDA Technical Report 13, Revised, (TR 13), Fundamentals of an Environmental Monitoring Program This TR, a long-standing best seller, serves as a resource on controlled environments test methods, focusing primarily on microbiological control for sterile product manufacturing. (Some nonviable particulate information is also included.) This second revision reflects substantial changes to regulatory guidelines, international standards, and scientific advances in environmental monitoring procedures and equipment. PDA Technical Report 26, (TR 26), Revised 2008, Sterilizing Filtration of Liquids This revision to the original TR 26 was developed in response to enhancements in filtration technologies and additional regulatory requirements within the pharmaceutical industry. References to scientific publications and international regulatory documents are provided where more detail and supportive data may be found. PDA Technical Report 60 (TR 60), Validation: A Lifecycle Approach Timely, real-world guidance for the application of a lifecycle approach to process validation is presented in this TR. It reviews requirements for process validation studies across the three-stage approach defined by the U.S. FDA and discusses best practices for integration with supporting quality systems. PDA Technical Report 79 (TR 79), Particulate Matter Control in Difficult to Inspect Parenterals This TR describes best practices for difficult-to-inspect parenteral (DIP) product lifecycle management, destructive testing, and trending to supplement portions of the guidance given in the USP General Chapter <1790>: Visible Particulates in Injection. It is intended to provide logical pathways to DIP product inspection and testing to support continual process improvement in the industry.