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**PRE-SALE! Full title will be released on 6/16/2025.**Volume 9 of the Environmental Monitoring series provides insight on methodologies for establishing an environmental monitoring program. There are a total of 19 chapters authored by leading experts in this area. This latest volume in this series …

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 …

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 …

Hardcopies are available for purchase at the Euromed Communications website .An in-depth comprehensive survey of QC pharma methods in the microbiology laboratory to enable a better understanding of these methods, and to ensure better developed, more compliant, expedited procedures.The reference …

PDA Technical Report No. 73-2: Application of Medical Device Regulations, Annex I Requirements for Staked Needle Syringes represents the current state of knowledge as to the application of European Union Regulation (EU) 2017/745 on medical devices (MDR).Since this regulatory requirement is new, expectations …

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 …

This technical report expands on the latest concepts and tools for improving PAC management, as published in ICH Q12. It provides a practical guide for the pharmaceutical industry on how to implement PACs within the framework of an effective pharmaceutical quality system (PQS) and in alignment with …

Hardcopies are available for purchase at the Euromed Communications website .The contamination control of pharmaceutical and healthcare environments and processes, together with pre-clinical drug development labs, requires a far more holistic approach than simply choosing technologies and …

PDA Technical Report No. 43 (Revised 2023): Identification and Classification of Nonconformities in Moulded and Tubular Glass Containers for Pharmaceutical Manufacturing provides an approach to a quality decision-making process and represents best practices for the identification and classification …

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 …

Since health authorities have not yet published guidelines for a comprehensive control strategy specific to microbiological topics for ATMPs, it is up to the individual ATMP sponsor or license holder to apply these compendial references properly. This Points-to-Consider document provides a summary of …

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 …