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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 …

The focus of this book is to provide a way to prepare for an FDA inspection of a non-sterile facility by reviewing relevant Warning Letters recently issued. The number of Warning Letters issued by FDA has been rising in recent years. The FDA publishes Warning Letters in its Electronic Reading Room available …

This book provides current information on the risk management process as it applies to health and safety of health products, drugs and biologics, medical devices and products that are a combination of two or more of these. The application of the processes will help manufacturers of these products to …

The focus of this book is to provide a way to prepare for a FDA inspection of an aseptic facility by reviewing Warning Letters recently issued to pharmaceutical companies. The number of Warning Letters issued by FDA has been rising in recent years. The FDA publishes Warning Letters in its Electronic …

PDA's newly released Technical Report No. 76 (TR 76) Identification and Classification of Nonconformities in Elastomeric Closures and Aluminum Seals for Parenteral Packaging provides a building block for developing a comprehensive specification for elastomeric components and aluminum seals. It offers …

Aging facilities contribute to a variety of challenges in pharmaceutical manufacturing, including drug shortages and product recalls. In response to calls for support in this area from industry and regulators, PDA established an Aging Facility Task Force to focus on the identification and modernization …

Avoidance of hazards and assessment of risk have long been part of the manufacture of pharmaceuticals and healthcare products. A high quality drug product must be free from contamination and reliably deliver the intended therapeutic dose as stated on the label and to achieve this manufactures must always …

PDA's newly released Technical Report No. 75 (TR 75) Consensus Method for Rating 0.1µm Mycoplasma Reduction Filters describes a consensus filter challenge test for standardizing test parameters across laboratories. This report educates users and filter manufacturers about best practices for mycoplasma …