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PDA/DHI Publications

The Parenteral Drug Association (PDA) offers practical guides for specific topics facing practioners in the pharmaceutical industry.

Selected books are available in the Maas & Peither Webshop:

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Pharmaceutical Outsourcing
Quality Management and Project Delivery

a comprehensive, practical guide with the goal of offering sound, reasonable advice to the outsourcing community focusing mainly on contract manufacturing

 
 
Cleaning and Cleaning Validation
Volume 1 and 2
Cleaning and Cleaning Validation is a series of volumes containing current knowledge and approaches to cleaning and cleaning validation of pharmaceuticals, medical devices, and associated products.

 
 
Combination Products
Implementation of cGMP Requirements

 
 
PDA Technical Report No. 60 Process Validation
(TR 60)

Interpretation of the requirements of FDA and EMA on the life cycle approach.

 
 
Computer Infrastructure Qualification For FDA Regulated Industries
This book provides practical information to enable compliance with computer infrastructure requirements including the verification activities related with the design and deployment.

 
 
Microbiology in Pharmaceutical Manufacturing
Volume I and II

The goal of this book is to provide updated and expanded microbiological information for the benefit of a global audience of stakeholders.

 
 
Practical Aseptic Processing Fill and Finish
Volume I and II
These books provide an overview of the aseptic process in the pharmaceutical industry. This process has received a lot of attention, since it is the most demanding of manufacturing processes.

 
 
Risk Assessment and Risk Management in the Pharmaceutical Industry
Clear and Simple

This book explores the phases of the risk management process in detail and examines how the various tools can be applied in identifying hazards and evaluating their potential impact and affects.

 
 
Quality by Design
Putting Theory Into Practice

 
 
GMP In Practice
Regulatory Expectations for the Pharmaceutical Industry

 
 
Environmental Monitoring – A Comprehensive Handbook
The Environmental Monitoring series edited by Jeanne Moldenhauer provides guidance through the ins and outs of the multitudinous aspects of compliance.

 
 
 
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