Journal Articles related to Quality Management and Compliance
Journal Article
The COVID-19 pandemic exposed significant challenges in the pharmaceutical global supply chain, leading to severe shortages of drugs and vaccines worldwide. This resulted in a pronounced inequity in distribution, particularly disadvantaging the Global South. This disparity is largely due to the dependency of low- and middle-income countries (LMICs) on pharmaceutical manufacturing in more industrialized nations. To mitigate this inequity and ensure supply of medicinal products across the globe, manufacturing of medicinal products needs to be decentralized through the establishment of manufacturing sites in LMICs.
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Londa Ritchey’s expertise in quality operations, oversight, and management has been integral to PharmaLex’s success. Leveraging her strong background in microbiology and biostatistics, she effectively manages operational plants, supervises global manufacturers, and navigates complex challenges, ensuring the highest standards in the pharmaceutical sector. In an interview with Pharma Tech Outlook Europe, Londa shared her positive outlook on emerging pharmaceutical manufacturing trends and the promising uptake of rapid micro methods, enabling swift responses to challenges.
Journal Article
On November 23, 2023, the PDA Ireland Chapter hosted an event on Microbiology – The Key to Compliance with Annex 1 and Risk Based Regulations. This sold-out event was led by industry leaders, experts, regulators, and pharmaceutical company representatives and was attended by professionals from across Ireland as well as overseas.
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Aseptic manufacturing of medicinal products has evolved rapidly over the last number of years, as a result of the development of numerous new applications and technologies.
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Change management is integral to ensuring appropriate implementation and maintenance practices for pharmaceutical quality systems (PQS). Effective change management systems ensure that innovation and continual improvement are facilitated, that change is appropriate and proportionate, and that key personnel take a level of ownership of the change. Processes related to change management must include an understanding of the current state and a vision for the future state.
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Effective change management systems ensure that innovation and continual improvement are facilitated, that change is appropriate and proportionate, and that key personnel take a level of ownership of the change. Processes related to change management must include an understanding of the current state and a vision for the future state.
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.
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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.
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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.