Navigating the Asia Pacific Pharmaceutical Landscape for Global Impact
Cover: The Asia Pacific region (APAC), like any large territory, encompasses a blend of well established and early-stage economies, diverse healthcare systems, and differences in language, culture, politics, and technology adoption. APAC’s size and complexity has created new challenges and opportunities for the pharmaceutical industry as nations work together to meet the manufacturing needs for medical products.
Evolving China’s Regulatory System In Alignment With ICH
Feature: With the Chinese government initiating drug regulatory reform in 2015 and China joining the International Council for Harmonisation (ICH) in 2017, a significant number of measures have been implemented by the government. The aim is to make fundamental changes to China’s drug regulatory administration system so it can facilitate pharmaceutical development and better meet patient needs in the country.
Digital Display Labeling in Clinical Supplies for Clinical Trials
Feature: Digital display labels (DDLs) offer an alternative solution to eliminate manual relabeling in the clinical supply chain, optimizing label content updates through a simple, system controlled approach while providing new, uncharted opportunities. With increased efficiency in making regulatory-compliant changes and enhanced flexibility in the clinical supply chain, DDL technology has the potential to revolutionize drug development and to increase and expedite patient access to therapies.
Risk- And Science-Based Media and Buffer Mixing Validations
The validation of media and buffer mixing is a continuing area of resource constraint in the pharmaceutical industry. These validations require materials, validation associates’ time, and the use of equipment and processing areas. This article proposes a risk-based life cycle for minimizing mixing validation resource inputs, with the objective of optimizing validation efforts through the use of recipe bracketing and predictive methods to identify the worst-case recipes that should be validated.
Electrochemical Techniques for Onsite Surface Qualification
Pharmaceutical critical utilities are typically built of 316L stainless steel; nevertheless, surface degradation has been reported due to the occurrence of different phenomena. This article aims to explain how field electrochemical techniques using a portable tool can be an effective method for surface inspection, qualification, and monitoring. The surface finish assessment considered different average roughness, obtained by mechanical polishing and electropolishing, and whether the surface was chemically passivated or not, to generate distinct passive films. This was done to prove the sensitivity of the field electrochemical tool using corrosion techniques.