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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

 
 
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.

 
 
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.

 
 
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.

 
 
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.

 
 
Quality by Design
Putting Theory Into Practice

 
 
GMP In Practice
Regulatory Expectations for the Pharmaceutical Industry

 
 
 
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