A Model for Pharmaceutical Supply Chain Quality Agreements

7 Mar 2014

Regulatory agencies around the globe have defined A Quality Agreement (QA) as a written document outlining the roles and responsibilities for the owner of the drug and the Contract Manufacturing Organization (CMO) in terms of basic cGMP regulations. This white paper presents a model for pharmaceutical supply chain Quality Agreements and discusses their importance.

Marken Preclinical Services

Marken

Serving preclinical research laboratories in over 150 countries and facilitating your preclinical research quickly and efficiently. As experts in time and temperature critical shipments for over 30 years, Marken understands the importance of providing reliable supply chain support throughout the drug development process, including early R&D activities and preclinical safety testing.Marken provide global shipping solutions for your biological specimens and drug product, with door-to-door service to and from your testing site, manufacturing facility, or bioanalytical laboratory. They also provide special packaging and temperature management, including topping off dry ice, replacing gel packs, and temperature monitoring throughout the logistic chain, as required to meet optimal stability for your shipment. Since specimens often need to cross country borders, experts provide regulatory and customs support to help move your shipment speedily through the often complicated process.Marken are USDA licensed and able to handle DEA controlled substances, infectious material, radiolabeled materials, and other dangerous goods.

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Marken API Services

Marken

Marken’s network fulfills the global movement of API from the point of manufacturing to CMOs and primary packagers. Marken optimizes API logistics around the globe with continuous temperature monitoring, documented transit custody and a worldwide network of offices, providing end-to-end quality-assured supply chain services.With Marken’s experience and expertise they excel in assisting companies to achieve the most expeditious movement of API’s across country borders. By working closely with customs officials, licensed customs brokers, and using their knowledge of import and trade compliance regulations, Marken is able to provide their customers with all of the details necessary to achieve the lowest possible duty and avoid delays each time a product is being shipped.Logistics capabilities offered for all ranges of temperature control include: Complete real-time reporting of the status of shipments Manufacturing supply chain expertise Customs preclearance Packaging, documentation and declarations consulting Regulatory and import/export license assistance and advice Insurance coverage

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A Model for Pharmaceutical Supply Chain Quality Agreements