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*Premium members: Download your free copy by 12/5/2025!*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 …

*Premium members: Download your free copy by 11/29/2025!*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 …

*Premium members: Download your free copy by 11/23/25!*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 …

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 …

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 …

Hardcopies are available for purchase at the Euromed Communications website. Since the publication of the first Quality Risk Management (ICH Q9) guideline in 2005 and the Risk Assessment and Risk Management in the Pharmaceutical Industry: Clear and Simple book by James Vesper in 2006, the pharmaceutical …

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 …

This survey was conducted to gather information on the implementation of the new EU GMP Annex 1 and implementation of barrier systems. This was a blinded survey. The Survey opened on 19 July 2023 and closed on 11 Aug 2023. In cases where a respondent only completed the first …

The survey was focused on companies that have sterile product manufacturing operations in the European Union, United Kingdom, or United States. For companies that have operations outside of the European Union, United Kingdom, or United States that wanted to take part in the survey, there was an option …

Companies producing sterile drug products must remain compliant with all regulations and requirements for current good manufacturing practices (cGMP) for any country or region where they wish to manufacture and market their products. Each regulatory authority presents their requirements through differing …

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 …

Hardcopies are available for purchase at the Euromed Communications website. Within the pharmaceutical and healthcare sector, validation and qualification form an important part of the quality system. However, understanding the differences between different regulatory agencies and the recommendations …

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 …