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PDA's Points to Consider for Aging Facilities takes into account the industry's general thoughts and suggestions of the pharmaceutical manufacturing industry on how to identify and modernize aging facilities. This document reviews:How to recognize that a facility is aging Impediments to modernization …

Here is the most important text discussing aseptic and sterile manufacturing to be published in the last decade that looks at both today and tomorrow in regard to these two vital processing procedures.The Editors realized that there was an urgent imperative for the relevant subjects to be reassessed …

PDA's Technical Report No. 54-5, Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems provides practical guidance on how to manage quality risks throughout the manufacturing system lifecycle and illustrates concepts through two case studies. The information …

Sale - 20% off! Original Price US$265 PDA Member, US$329 Nonmember, US$180 Government Sale prices are already displayed and will be reflected during checkoutIn Destin LeBlanc's Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Vol. 3 pharmaceutical manufacturers and …

Sale - 20% off! Original Price US$265 PDA Member, US$329 Nonmember, US$180 Government Sale prices are already displayed and will be reflected during checkoutThis book complements Cleaning Validation: Practical Solutions for Pharmaceutical Manufacturing, Volume 1. It contains modifications and updates …

Sale - 20% off! Original Price US$265 PDA Member, US$329 Nonmember, US$180 Government Sale prices are already displayed and will be reflected during checkoutCleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing by Destin LeBlanc contains a complete, modified and updated …

Pharmaceutical Manufacturing: Understanding Your Process Series Environmental Monitoring, Volume 2: Practical ApproachesIn the past 15 years, PDA/DHI has published more than 1,000 practical scientific and regulatory chapters, written by global subject matter experts, which have been designed to help …

Pharmaceutical Manufacturing: Understanding Your Process Series Environmental Monitoring, Volume 1: Establishing the ProcessIn the past 15 years, PDA/DHI has published more than 1,000 practical scientific and regulatory chapters, written by global subject matter experts, which have been designed to …

Pharmaceutical Manufacturing: Understanding Your Process Series Sterilization: Practical ApproachesIn the past 15 years, PDA/DHI has published more than 1,000 practical scientific and regulatory chapters, written by global subject matter experts, which have been designed to help pharmaceutical and …

Pharmaceutical Manufacturing: Understanding Your Process Series Sterilization: Establishing the ProcessIn the past 15 years, PDA/DHI has published more than 1,000 practical scientific and regulatory chapters, written by global subject matter experts, which have been designed to help pharmaceutical …

Pharmaceutical Manufacturing: Understanding Your Process Series Cleaning and CleanroomsIn the past 15 years, PDA/DHI has published more than 1,000 practical scientific and regulatory chapters, written by global subject matter experts, which have been designed to help pharmaceutical and biotech manufacturers …

Volume 4 complements Destin LeBlanc's earlier three books on the same subject. This book modifies and updates LeBlanc's monthly Cleaning Memos originally published from January 2013 through December 2016. More than half of the chapters in the book are on setting limits in one way or another, so the use …

PDA's Technical Report 60-2: Process Validation: A Lifecycle Approach - Oral Solid Dosage/Semisolid Dosage Forms Annex builds on and illustrates how concepts from TR 60 can be applied to oral solid dosage and semisolid dosage drug products so that the reader can gain a clear understanding of the application …

Effective Implementation of Audit Programs provides current perspectives on informal and formal audits.Written by Miguel Montalvo, who has more than 32 years of extensive experience in the areas of cGMP compliance, quality operations/systems and validation functions/responsibilities, this book applies …

PDA's newly released Technical Report No. 77 (TR 77), The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology provides recommendations specific to the operation of blow-fill-seal (BFS) technology for the manufacture of sterile pharmaceuticals (e.g., ophthalmic, …

The book primarily focuses on parenteral products and the excipients, but the methodology can transfer to other areas of microbiology as well. The book also provides advice on programs and special studies that might be performed in the pharmaceutical microbiology laboratory. The purpose of this book …

This book is intended to provide a background to the quality control (QC) microbiology function from the perspective of the laboratory, and particularly from that of the laboratory manager. Sutton focuses on the role of the QC microbiology laboratory in the pharmaceutical manufacturing …

This book has been prepared to address the requirements which are stated in the Guide to the Knowledge and Practical Experience Required by Qualified Persons in the Pharmaceutical Industry (the "Study Guide") in relation to pharmaceutical microbiology.This reference guide will help QP candidates …

This book discusses the basic concepts necessary to the understanding of Biological Indicators and includes the history of biological validation and general principles, the kinetics of microbial inactivation and factors affecting resistance as well as guidance in understanding bacterial endospores …

PDA’s newly revised PDA Technical Report No. 56, Revised 2016 Application of Phase-Appropriate Quality System and cGMP to the Development of Therapeutic Protein Drug Substance provides an overview of the ideal state for broad good manufacturing practices (GMPs) throughout the product lifecycle and as …