Journal Articles related to Quality Management and Compliance
Journal Article
Pharmaceutical companies increasingly rely on Contract Development and Manufacturing Organizations (CDMOs) to bring efficiency, flexibility, and innovation to their operations. As partnerships with CDMOs become critical to achieving business objectives, it is imperative for pharma companies to choose the right partners and manage these relationships effectively. To shed light on how pharma companies can optimize CDMO collaborations, we spoke with Annette Boland, a seasoned Quality & Compliance Executive at PharmaLex, a Cencora Company.
Journal Article
The use of contract development manufacturing organisations (CDMOs) is now the established norm in the pharma/medtech supply chain. The CDMO model provides cost-effective, reliable and compliant solutions with speed to market for critical healthcare products. It takes advantage of core competencies/experience from the contract giver (eg, brand development, marketing, etc) and contract acceptor (eg, manufacturing excellence, quality operations, etc) to allow for targeted focus on key operational pillars to ensure overall programme success and synergies.
Journal Article
The steps to commercialization readiness are complex, multi-faceted and often left too late in the launch strategy of a pharmaceutical product. This can be particularly problematic in Europe where the diversity of national legislation can make supply chain logistics very challenging. Among the issues faced, particularly for non-EU countries, are defining the product’s logistics, identifying stakeholders who will be involved in the supply chain in Europe, and ensuring that all these individuals are ready to assume their roles soon after the product’s approval (Marketing Authorization) with the relevant Licences and Quality Technical agreements in place.
Journal Article
One of the biggest challenges when launching a product in the EU is understanding the complex regulatory landscape. Besides the overarching European legislation, each country has its own national requirements for the supply of medicinal products.
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.
Journal Article
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.
Journal Article
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.
Journal Article
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.
Journal Article
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.
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.