A Vision for ICH Q12: Current Experience, Future Perspectives
Cover: Management of global postapproval chemistry, manufacturing, and controls changes is a growing challenge for industry with many issues. ICH Q12 (Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management) is a transformative document shaping global regulatory postapproval submissions that will help alleviate some of these issues.
ICH Quality Guidelines: Present Initiatives and ISPE Involvement
Feature: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has covered a wide range of topics to generate quality, safety, e cacy, and multidisciplinary harmonized guidelines. This article summarizes all quality and related multidisciplinary guidelines and discusses new topics and ISPE’s role in guideline development and implementation.
Distant Assessments, Audits, and Regulatory Guidance
Feature: The ISPE Global Pharmaceutical Regulatory Summit, held virtually on 28 April 2021, brought together 11 regulators from different parts of the world to discuss how their approaches to GMP inspections have adapted to the COVID-19 pandemic.
Pharmaceutical Cleanroom Design and ISO 14644-16
TECHNICAL: Cleanrooms and controlled contamination environments are increasingly being used across many industrial sectors, including the pharmaceutical industry. An important issue is the operating cost associated with cleanroom energy consumption and, consequently, the identification of applicable energy containment measures. This article reviews pharmaceutical cleanroom calculations for non-unidirectional airflow against energy consumption with known sources of contamination and type of air diffusion used. It proposes alternative cases to compare potential economic savings from applying energy-saving measures proposed by ISO 14644-16.
Temperature and Humidity Requirements in Pharmaceutical Facilities
TECHNICAL: Defining room temperature and humidity limits is a frequent topic of debate when designing and operating pharmaceutical and biotechnology facilities. What are appropriate alarm limits and acceptable durations for an alarm condition? Understanding the source of temperature and humidity requirements, and strategies for setting limits, can ensure both compliance and optimum use of energy. This article provides guidance on these topics, with supporting rationales.