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PDA/DHI Publications

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

 
 
 
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
Second Edition, Revised and Expanded, 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.

 
 
Risk-Based Compliance Handbook
This book covers all stages of the drug lifecycle from R&D, to the clinical phases, the launch and pharmacovigilance stages, and the discontinuation step.

 
 
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.

 
 
 
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