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This Points to Consider document aims to assess the feasibility and requirements for designing and qualifying a self-contained manufacturing process that, once validated, can be relocated and operated in a different location for the same process, without the requirement for regulatory preapproval …

This Points to Consider document considers the facility, utilities, and process equipment designs necessary to support the manufacture and testing of ATMP therapies (autologous and allogeneic). Ideally, the design considerations should be weighed upfront to ensure the process meets the respective …

Technical Report No. 22 (Revised 2025): Process Simulation for Aseptically Filled Products replaces the previous revision of PDA Technical Report No. 22: Process Simulation Testing for Aseptically Filled Products published in 2011. The intent of the current effort is to update that document to reflect …

The scope of this survey encompasses the evaluation of industry practices, challenges, and perspectives related to the implementation of the PUPSIT requirement as outlined in Annex 1 of the EU GMP Guide, effective August 2022. The survey targeted professionals and organizations involved in sterile drug …

This Points to Consider document represents the views of the Parenteral Drug Association (PDA). The document is designed to communicate PDA’s thoughts and considerations pertaining to the design, operation, and use of Restricted Access Barrier Systems (RABS) for aseptic processing, processes subjected …

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 …

The 2020 PDA Research Particulate Matter in Flexible Containers Survey was undertaken to address the industry-wide concern raised by multiple recalls for particulate matter in flexible container and other container products dating back to 2012.This survey was conducted to establish a benchmark of current …

This chapter is taken from the book Fungi: A Handbook for Life Science Manufacturers and Researchers, edited by Jeanne Moldenhauer.There is a major gap in understanding fungi in general and mold specifically in the pharmaceutical industry. Most mycologists are in academia and fungi are not taught in …

The form FDA 483, "Inspectional Observations," is a form used by the FDA to document and communicate concerns discovered during the inspections of medical device manufacturing plants. This booklet takes the publicly available yearly inspection data from the U.S. FDA and presents it in a more …

This publication provides a summary and analysis of publicly available yearly observation data for drug product manufacturers from the U.S. FDA and presents it in a more useful, digestible format. It includes an analysis of trends in observations and a breakdown of the most common observations from …

This chapter is reprinted and available individually from Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers, Volume 1 edited by Siegfried Schmitt, a text that collects in one place invaluable and comprehensive regulatory, manufacturing and distribution guidance and …

This chapter is reprinted and available individually from Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers, Volume 1 edited by Siegfried Schmitt, a text that collects in one place invaluable and comprehensive regulatory, manufacturing and distribution guidance and …