\nand are now reaching record highs2<\/sup> around the world<\/a>. Currently,
\nin the U.S., several oncology drugs are being rationed, while
\nmany workhorse antibiotics and analgesics are not available.
\nAccording to a recent EU report3<\/sup>, three-quarters of EU member
\ncountries experienced inadequate supplies of key therapies.
\nMeanwhile, the American Society for Hospital Pharmacists\u2019
\nlatest report found that 301 shortages occurred during the
\nfirst quarter of 2023 alone, twice the number that had been
\nseen in 20184<\/sup>.<\/p>\n
For the past decade, as shortages have intensified, regulators and industry organizations have European regulators launched similar efforts in 2016 and issued guidance6<\/sup> Evolving initiatives such as Identification of Medicinal ³Ô¹Ï±¬ÁÏ (IDMP)7<\/sup>, As drug supply gaps have worsened, the industry continues to increase its reliance on outsourcing, The industry\u2019s continued reliance on traditional legacy software has only intensified these challenges. One way to avoid these problems is by investing in technology that enhances collaboration and the When configuring these applications, each company decides what data and documentation each This approach is streamlining processes for sponsors and contract partners alike. Karyopharm Meanwhile, a diversified pharma company has configured Vault QMS so that customers and suppliers Connected, cloud-based systems can also streamline the management of post-approval Each of these manual processes can entail hundreds of different steps and detailed interactions Today, the typical large biopharma company contends with thousands of these changes globally The result is a significant amount of manual work, as well as redundant data and work steps, Among the companies adopting this approach is Moderna Therapeutics. Linking its regulatory There is no single remedy for drug shortages, but a growing number of companies are reducing risks To learn more about how your peers are using these approaches to improve operational excellence See how ³Ô¹Ï±¬ÁÏ streamlines change control<\/a>.<\/p>\n 1<\/sup> U.S. Senate Committee on Homeland Security, \u201cShort Supply: The Health and National Security Risks of Drug Shortages,\u201d Final Report, Global drug shortages are at record levels. Real-time unified data access is crucial for mitigating shortages in collaboration with external partners.<\/p>\n","protected":false},"featured_media":75676,"parent":0,"template":"","class_list":["post-79924","resources","type-resources","status-publish","has-post-thumbnail","hentry","resource-html-content-yes","resource-area-20-quality","resource-product-20-qms","resource-product-20-qualitydocs","resource-type-white-papers"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources\/79924"}],"collection":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources"}],"about":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/types\/resources"}],"version-history":[{"count":1,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources\/79924\/revisions"}],"predecessor-version":[{"id":79925,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources\/79924\/revisions\/79925"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media\/75676"}],"wp:attachment":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media?parent=79924"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
\nproposed risk-based measures to ensure adequate drug supplies. In 2018, during a national drug
\nshortage crisis, the U.S. Food and Drug Administration (FDA) set up a task force that recommended
\nincentives to spur investment in Quality Management Maturity (QMM), while the International Society
\nfor Pharmaceutical Engineering (ISPE) has studied best organizational practices for preventing
\nshortages (Figure 1<\/strong>).<\/p>\n![\"\"](\"\/eu\/wp-content\/uploads\/2024\/10\/Mitigate-Drug-Shortage-Risks-by-Improving-Internal-and-External-Collaboration-graphic-1.png\")
<\/p>\n
\nin 2023. Its goal is to help
\nmarketing authorization holders, wholesalers, distributors, and manufacturers optimize their response
\nto drug shortages resulting from GMP noncompliance. It also includes best practices learned during
\nthe COVID-19 pandemic.<\/p>\n
\nPharmaceutical Quality, Chemistry, Manufacturing & Controls (PQ\/CMC)8<\/sup>,
\nand ICH Q129<\/sup> continue to address the need to
\nstandardize data and the exchange of information between stakeholders, to speed up communication
\nand decision making to improve drug availability. They aim to enable FDA and the European Medicine
\nAgency (EMA) to coordinate supply monitoring and management efforts. The European Community
\nhas also proposed regulatory reforms10 that would speed the commercialization of some generics
\nand biosimilar products to bolster supplies.<\/p>\nUnifying data to reduce the risk of drug shortages<\/h2>\n
\nassigning strategic functions to outside partners to reduce risk, speed time to market, and gain
\naccess to specialized expertise and resources11. Successful partnerships demand clear
\ncommunications and oversight to ensure process control, quality, and ultimately, trust.<\/p>\n
\nDisconnected information silos require that quality, regulatory, and manufacturing teams use
\nmanual efforts and communication methods such as email to connect and manage processes
\nand extend them to external partners. Relying on email to share documents and manage regulatory
\nsubmissions, deviations, audit findings, and complaints with contract partners creates risks and
\nhinders operational efficiency.<\/p>\n
\nsharing of relevant data \u2014 both internally, across functions, and between sponsors and contract
\npartners such as CDMOs and CROs. Cloud-based solutions gather information in one system and
\nprovide access to real-time quality, regulatory, and manufacturing data for all collaborators within
\nand outside of a company\u2019s boundaries (see Figure 2<\/strong>).<\/p>\n![\"\"](\"\/eu\/wp-content\/uploads\/2024\/10\/Mitigate-Drug-Shortage-Risks-by-Improving-Internal-and-External-Collaboration-graphic-2.png\")
<\/p>\n
\nof its external partners should have access to, in what form, and with what frequency. This ability to
\ntailor how partners receive information guarantees security while giving contract partners access to
\nthe most relevant, up-to-date quality information directly from the sponsor\u2019s quality management or
\ndocument management system (QMS or DMS). It also allows companies to configure solutions so
\nthat external partners can add information directly into their digital systems, eliminating the need for
\nemailing and rounds of verification, and reducing secondhand data-entry errors.<\/p>\n
\nTherapeutics is taking this approach with Vault QualityDocs to handle documentation with its
\nsuppliers<\/a>. Using the application, vendors can upload relevant quality and regulatory documents
\ndirectly into the sponsor\u2019s DMS, eliminating manual data entry, verification, and rounds of emailing.
\n\u201cVendor access is limited to what they can see, we don\u00b4t have to email documents, and we can find
\nthe documentation very easily,\u201d says Maria Conklin, associate director of QC.<\/p>\n
\nalike can key information directly into the system for audit findings and corrective and preventive
\nactions (CAPAs). Extending its QMS to partners has led to significant improvements in efficiency
\nand decreased costs. The company is already working on extending this collaborative approach to
\ncomplaints and deviations.<\/p>\nExpediting post-approval changes<\/h2>\n
\nmanufacturing changes, one of many root causes of drug shortages. Traditional approaches to
\nchange control use disconnected data, resulting in manual processes that delay batch release and
\nproduct availability. They require frequent communication and the close coordination of efforts
\namong production, quality, and regulatory teams.<\/p>\n
\namongst cross-functional teams as they work to track down historical data and documents. For
\ninstance, if a manufacturing process or specification has changed, regulatory teams must see which
\ncountries and internal documents will be affected, while supply chain teams would need to look at
\ndata for individual product information. Using legacy approaches, it is difficult and time-consuming
\nfor teams to find and verify the information and documentation required.<\/p>\n
\neach year \u2014 as many as 200 per product. Processing each change can take between six months
\nand two years to complete, due to lack of visibility into separate data and limited integration between
\nsystems that include QMS, RIM, LIMS, and ERP.<\/p>\n
\nincluding meetings, phone calls, and emails. Connecting quality to RIM systems eliminates data
\ndisconnects and enables process automation, reducing the time and effort required for change
\nmanagement. Figure 3<\/strong> shows how an integrated system works, including DMS and learning
\nmanagement systems.<\/p>\n![\"\"](\"\/eu\/wp-content\/uploads\/2024\/10\/Mitigate-Drug-Shortage-Risks-by-Improving-Internal-and-External-Collaboration-graphic-3.png\")
<\/p>\n
\nand quality applications has led to significant reductions<\/a> in the time needed for regional impact
\nassessments and last-minute coordination with supply chain and regulatory departments. \u201cNow, the
\ndata and information needn\u2019t be requested or sit in someone\u2019s inbox for two days,\u201d notes Juhi Saxena,
\nassociate director of regulatory and clinical platforms.<\/p>\nConclusion<\/h3>\n
\nand increasing agility by modernizing the way they approach quality and regulatory management,
\nunifying across people, partners, and systems. Some are going one step further by connecting
\nquality with regulatory data and documentation to eliminate manual processes. The result is better
\ncollaboration \u2014 both internally, across functions, and with external partners \u2014
\nto speed availability of treatments to
\nthe patients who need them.<\/p>\n
\nand minimize supply disruptions, and how ³Ô¹Ï±¬ÁÏ is optimizing its quality and regulatory platform to
\nmeet these needs, please contact Sofia Lange<\/a>, director of strategy for quality and manufacturing,
\nor Vicki Cookson<\/a>, enterprise strategy lead for regulatory affairs, at ³Ô¹Ï±¬ÁÏ Systems.<\/p>\n
\n
\nJune 6, 2023.
\n2<\/sup> Lovelace, B. \u201cOne in Three US Hospitals Severely Affected by Drug Shortages, Survey Finds,\u201d<\/a> NBC News, August 10, 2023.
\n3<\/sup> PGEU, \u201cMedicine Shortages Survey Results,\u201d<\/a> 2022.
\n4<\/sup> American Society of Hospital Pharmacists Webpage on Drug Shortages<\/a>, 2022.
\n5<\/sup> FDA, \u201cDrug Shortages: Root Causes and Potential Solutions,\u201d<\/a> 2019.
\n6<\/sup> EMA, \u201cRegulatory Procedural Guidelines for the Prevention of Drug Shortages,\u201d<\/a> 2023.
\n7<\/sup> EMA, \u201cData on Medicines (ISO IDMP Standards) Overview,\u201d<\/a> 2016.
\n8<\/sup> FDA, \u201cPharmaceutical Quality \u2013 Chemistry, Manufacturing & Controls (PQ\/CMC),\u201d<\/a> 2023.
\n9<\/sup> EMA, ICH Q12 \u201cGuidelines for Considerations of Pharmaceutical Product Lifecycle Management,\u201d<\/a> 2023.
\n10<\/sup> EC, \u201cAmendment to the Proposal for Regulation of Medical ³Ô¹Ï±¬ÁÏ to be Authorized by the Union,\u201d<\/a> 2023.
\n11<\/sup> \u201cPredicted Growth in the Outsourcing R&D Sector\u201d, TechTeamz.io, March 28, 2023.
\n<\/footnotes><\/p>\n","protected":false},"excerpt":{"rendered":"