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This American National Standard (ANS) evaluates various guidance documents, models, and tools to measure and provide a better understanding of quality culture for the pharmaceutical/medical device industry. The standard identifies 5 key focus topics with attributes, characteristics, and measurements …

This standard provides a lifecycle approach using a holistic evaluation of contamination control systems designed to minimize and/or prevent contamination during aseptic processing and ultimately ensure the safety of the products when delivered to the patient. The standard is also applicable to aseptic …

This Points to Consider document is focused on the use of viral vectors for delivery of a therapeutic gene, both in vivo and for ex vivo modification within the overall classification of ATMPs. The topics addressed are diverse and include plasmid and viral vector categorization and control, quality …

PDA Technical Report No. 46 (Revised 2024): Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to End Users complements the information provided in Technical Report No. 39 (Revised 2021): Guidance for Temperature-Controlled Medicinal Products — Maintaining the Quality …

PDA Technical Report No. 68: Risk-Based Approach for Prevention and Management of Drug Shortages was originally developed in 2014. The approach to risk-based prevention of drug shortages presented in this revision remains unchanged. This revision focuses on updating references and progress related …

As a result of the COVID-19 pandemic, many industries-the pharmaceutical included-went through a substantial disruption.Some of these disruptions included facility shutdowns, unprecedented supply chain challanges, worker availabitlity, and quality system limitations (e.g. physical signatures, …

This document provides points to consider on topics related to the physical environment in which aseptic processing is conducted, monitoring of that environment, cleanroom personnel, material transfer, aseptic process simulation and validation, modern blow-fill-seal technology, cleaning, disinfection …

Drug manufacturers have employed contamination control measures for decades as a core element of good manufacturing practices. Commonly, these are a collection of generic practices that were developed separately and applied without clear consideration for their interdependence. The ongoing evolution …

This report describes different strategies that can be applied to manage the development and lifecycle of vaccine products. The concepts covered are intended to apply to different types of vaccines, for which "real world" examples are provided. In some cases, the strategy may involve extensive retrospective …

The 2021 PDA Aseptic Process Simulation for Sterile Bulk Pharmaceuticals Survey was designed to provide insight on current industry practices of the aseptic process simulation (APS) used in the production of aseptically produced sterile bulk pharmaceuticals. There were 42 respondents with the survey …

Technical Report No. 41 (Revised): Virus Retentive Filtration, provides a summary of best practices for utilization of virus filtration in process development and manufacturing. The document explains what virus filters are and where they can be used in current and emerging bioprocesses. Recommendations …

This technical report aims to provide a standardized approach to the technology transfer process. It supplies a matrixed "Reference Guide to Technology Transfer Activities and Deliverables," which can be used to coordinate cross-functional technology transfer activities that help achieve operational …

This revision of TR 13 aligns with current industry trends and regulatory expectations and provides additional guidance and focus on increased expectations concerning data management and data integrity, qualification and maintenance of controlled environments, and rapid microbiological methods …

ANSI/PDA Standard 02-2021: Cryopreservation of Cells for Use in Cell Therapies, Gene Therapies, and Regenerative Medicine Manufacturing: An Introduction and Best Practices Approach on How to Prepare, Cryopreserve, and Recover Cells, Cell Lines, and Cell-Based Tissue ProductsThis new standard provides …

This technical report presents a holistic approach for performing a microbiological investigation. It provides a framework to assist with focusing on the investigational areas that may contain or contribute to the root cause of data deviations, such as sampling, test methodology, and suitability of the …

This technical report provides guidance for establishing a quality management system for distribution of all types of temperature-sensitive medicinal and pharmaceutical products. This guidance covers the shipping site, where the product is prepared for transportation, and the shipment of the …

This technical report focuses on a technical understanding of glass, its strength, and its limitations, and provides guidance in best handling practices for glass vials throughout the pharmaceutical process — receipt, storage, preparation, filling, stoppering, freeze-drying, and capping. This document …

This new standard describes a filter challenge test for standardizing test parameters across laboratories using 47 mm discs and using A. laidlawii as the test organism. While this standard is primarily to educate users and filter manufacturers about best practices for mycoplasma reduction …

This technical report is a consensus-based resource surrounding the challenges encountered in using complex package systems and introduces important elements to consider in decision-making. It also offers an examination of the technologies available for package integrity testing not yet established by …

Visual inspection of filled injectable products is an important part of the control strategy of the manufacturing process. It offers a means to improve quality by removing noncompliant units and provides information to drive continuous process improvement. This technical report addresses test and inspection …