Contents

 POLICY AND REGULATION

          Standards Lead Innovation and Regulation Drives Development

          Usage of ICH Q12 in Drug Products Life-cycle Management (III)

                                 Change Prediction and Implementation: PACMP

TECHNICAL COMMUNICATION

          Moving Forward towards Standardized Analytical Methods for Unknown Extractables and Leachables Profiling Studies

          Revived Focus on Risk assessment of Nitrosamines in Pharmaceuticals

          Reliably determined – precisely dosed – for maximum user safety

COMMUNICATION CORNER

          The Influence of Ash Content and Treatment Process on Freeze-dried rubber stopper

          Study on Uncertain Factors of Alkaline Resistance Test Method for Medicinal Glass

  The need to introduce vision inspection system

          TPE Co-injection Technology Drives the Quality of IV Packaging to Scale a New Height

MEDICAL CONSUMABLES

          Antioxidants and Their Degradation Products in Plastics and Elastomers for Pharmaceutical Use

          COP Polymer Material Prefillable Syringe

PACKAGING DESIGN

  Polymer Syringes plus Functional Labels – A Perfect Combination with Added Value

          Innovative Solutions for Packaging Biologics

WINDOW OF KNOWLEDGE POPULARIZATION

 Supply Chain Security White Paper:

Prevention of Re-use of Genuine Packaging Components for Counterfeit Products

Solutions to drug packaging container closure integrity testing (CCIT)

A Zero Defect Approach – The perfeXion® Quality Process