Bookstore Search

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 …

Sterilizing filtration is the process of removing microorganisms from a fluid stream without adversely affecting product quality (1-4). This technical report (TR) is intended to provide a systematic approach to selecting and validating the most appropriate filter for liquid sterilizing filtration …

The PDA Manufacturing Technology Guide No. 1: Aseptic Filling, Engineering, and Operation is designed to communicate the Parenteral Drug Association’s thoughts on the topic and encourage further dialog among industry, health authorities, and suppliers of technology and materials, taking into consideration …

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 document provides key Points to Consider for navigating the complexities of raw materials in the manufacturing of advanced therapy medicinal products (ATMP), aiming to guide stakeholders in establishing robust strategies for raw material management, promoting best practices, and supporting the safe …

Hardcopies are available for purchase on the Euromed Communications website.This book contains practical advice and insight to help different types of pharmaceutical organisations prepare for GMP inspections, understand key regulatory issues and review inspectorate trends and findings. The book compares …

Hardcopies are available for purchase on the Euromed Communications website.Volume 9 of the Environmental Monitoring series provides insight on methodologies for establishing an environmental monitoring program. There are a total of 18 chapters authored by leading experts in this area. This latest …

This survey aimed to gather industry benchmarking data on transportation qualification strategies within the pharmaceutical and biopharmaceutical industry. Specifically, the goal was to examine the application of simulated data to better understand how transportation conditions impact drug product …

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 …

In February 2015 the European Medicines Agency (EMA) and the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-operation Scheme (PIC/S) jointly issued a Concept Paper on the revision of the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary …

From November 2022 through January 2023, the fifth survey in a series of surveys on visual inspection was conducted by PDA to better understand current industry practices in this important area. Past surveys in 1996, 2003, 2008, and 2014 have provided practical guidance and insight to those working …

The Product Quality Research Institute (PQRI) Leachables and Extractables (L&E) Working Group provided recommendations to the US Food and Drug Administration in 2006 on safety thresholds and best demonstrated practices for orally inhaled and nasal drug products (OINDP). The published PQRI E&L …

There are very few documents available that provide guidance regarding to requirements for non-sterile drug manufacturing. The Kansai Study Group (KSG) of the PDA Japan Chapter (JPDA) published this paper to offer some consensus-based ideas to help pharmaceutical manufacturers establish appropriate, …

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 2021 PDA Post-Approval Change Issues and Impacts Survey provides experts' views on the most significant post-approval change issues faced by manufacturers of drug products (DPs) and active pharmaceutical ingredients (APIs). By understanding the challenges that industry faces in making manufacturing …