Regulating with Flexibility: The Pandemic Effect

Inspectors checking compliance with current good manufacturing practice (CGMP) have not been able to visit sites because of travel controls, social distancing rules, and other safety regulations. Challenges with checking compliance GMP is a key means for checking the safety and quality standards of...

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Bibliographic Details
Published in:Pharmaceutical technology Europe 2020-10, Vol.32 (10), p.6-8
Main Author: Milmo, Sean
Format: Article
Language:English
Subjects:
Coronaviruses
COVID-19 vaccines
Good Manufacturing Practice
Manufacturing
Pandemics
Online Access:Get full text
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Summary:Inspectors checking compliance with current good manufacturing practice (CGMP) have not been able to visit sites because of travel controls, social distancing rules, and other safety regulations. Challenges with checking compliance GMP is a key means for checking the safety and quality standards of new processes, and plant alterations and expansions, particularly on existing manufacturing sites. At the national level in Europe, controls on COVID-19 vaccines development and distribution are in danger of fragmenting as governments pursue their own methods for speeding up R&D and for providing access to specific groups of patients. [...]once COVID-19 is no longer categorized as a health emergency, many exemptions and relaxations of rules could be withdrawn.
ISSN:1753-7967