Journal Articles related to Quality Systems and Compliance

Journal Article
Companies in the life sciences industry must ensure they have the systems and tools to be able to consistently provide a product that is safe and effective and that is delivered in a timely manner to meet the needs of customers, in addition to an efficient and agile support system for resolution of unexpected situations.
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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