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