Journal Articles related to Commissioning, Qualification and Validation

Journal Article
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released a long-awaited draft revision of its Q9 guidance on quality risk management (QRM) for public consultation in December 2021  (1). First published in 2005, ICH Q9 has been instrumental in highlighting the importance of QRM in both the small- and large-molecule pharmaceutical industries.
Journal Article
Quality Risk Management Why is QRM important for a pharmaceutical organization? What’s an efficient QRM program? How QRM is implemented and applied across the product life cycle? What is the correct way of implementing QRM?
Journal Article
Maintaining regulatory compliance across the product lifecycle, from product development through commercialisation and market compliance, is critical to ensuring the continuity of your operations. Whether your organisation is virtual or fully in-house, auditing is a mandatory component of maintaining regulatory compliance.
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