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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 …

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 …

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 …

**Winter Booksale: 25% OFF!**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 …

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 …

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 …

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 …

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 Points to Consider document describes steps that can be taken to ensure an effective and efficient remote assessment. It introduces standard nomenclature to describe the types of remote audits and discusses key considerations for their scheduling, duration, planning, conduct, closing, …

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 …

Remote assessments increasingly are seen as useful tools in obtaining meaningful insights into a site's operations. But what factors should companies and health authorities consider when adjusting to a remote inspection format? How do you determine, address, and plan for the technological hurdles and …

In this book you will find many different approaches to conducting compliant investigations, where compliant is defined as meeting the requirements of the applicable regulatory documents. The information it provides on conducting investigations that will be acceptable to regulatory investigators will …

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 …

PDA's book, Quality by Design — An Indispensable Approach to Accelerate Biopharmaceutical Product Development, edited by industry experts Cristiana Campa, Vaccines Technical R&D, GSK, and M. Amin Khan , Vaccines R&D, GSK, is an important contribution to the ongoing dialogue for accelerating …

The concepts presented in PDA Technical Report No. 60-3 (TR 60-3): Process Validation: A Lifecycle Approach Annex 2: Biopharmaceutical Drug Substances Manufacturing are intended to assist in the design and implementation of globally compliant validation programs to ensure process reproducibility and …