Collapse Assessment for New ExportersNew-Exporter-Assessment This questionnaire for new exporters includes areas to consider when determining your level of export readiness, and provides an initial assessment of your exporting needs and capabilities.
The biopharmaceutical industry is not immune from disasters of a dizzying variety. But biotechnology companies often put all their supply needs in one proverbial basket. Companies need to understand fully the ramifications of contingency planning for single product lines. Imagine having to set up distribution and shipping plans for multiple products with different environmental needs, for shipping to different markets, and so on.
Business continuity planning will guide a company safely to the other side. But contingency plans are just that — plans — so they need to be made before something happens. Organizations need to ask difficult questions ahead of time so that they can be as prepared as possible to handle problems head-on.
Results will be unique depending on the possible risks and flexibility required to continue business with little or no interruption. What if your company has the best contingency plan, but a system is flawed even before that planning begins?
After customer complaints, lost revenue, and temperature excursions that could affect patient outcomes and results, the company needed a fresh set of eyes to conduct a more thorough risk assessment of its logistical operations.
After signing confidentiality agreements, the company invited Intelsius for a two-day site visit and evaluation of its shipping supplies, practices, and procedures. Those same products also could be shipped to overseas facilities for distribution in Europe and Asia.
Organization members include shippers that manufacture and distribute products, carriers that provide the means of distribution, organizations that supply packaging materials and services, and testing laboratories that perform packaged—product performance tests. ISTA develops and delivers standards, tools, and educational programs for the economic, social, and environmental optimization of packaging systems.
It wants to see all packaging systems designed and certified to ISTA performance and environmental standards. The organization helps its members control costs, lessen damage, and improve resource use during the distribution of packaged products by Creating and publishing packaged-product test procedures Certifying packaging laboratories, packaged products, and professionals Providing education, training, and support.
After a brief facility tour and visit to the shipping department, Intelsius began its assessment. Here are a few of the questions we asked: Are shipping components and systems ISTA qualified see box, next page? Are they regulatory compliant for carriers used in Asia, Europe, and the United States?
Does it have appropriate facilities and equipment to ensure that products and components are prepared properly for shipping? Are staff members properly trained in the dozen steps for packaging those products using current systems? And why are there a dozen steps?
Having a clear strategy for distribution of temperature-sensitive materials is critical to ensuring that a product is delivered to patients in optimal condition. Working with a temperature-controlled, regulatory-compliant packaging designer, manufacturer, and distributor will allow several factors to be considered early in product development.
Some suppliers may offer appropriate off-the-shelf options, but product-specific factors may require customized solutions. Risk assessment and strategy development begin with a few vital questions: At what temperature does your product need to be transported and stored?
Where does the drug need to go — international or domestic market s? During what season s will the product be distributed? What stability data are available? What are the size, mass, and dose format of the drug?
How is it packaged? How much of an investigational medicinal product IMP can each intended site receive and store safely from a single shipment? After addressing those simple questions, you can move on to the next step in risk assessment: Four types of data may be gathered for temperature mapping: To gather actual data, transport multiple placebo and real-product shipments on the actual routes to be used.
During those processes, explore key factors such as seasonality, deviations from standard operating procedures SOPsand adverse exposure frequency occurrences.
The averaged-data methodology reviews location-based sources such as historical temperature data to develop a temperature route map.The Export Readiness Assessment is a tool designed to help you better understand your readiness to begin or expand your exporting activities.
The assessment covers the four most critical areas of: Market, Product, Operations and Finance. Once completed the assessment results will be emailed to you. If your shipping processes aren’t running as smoothly as they could be or you’re paying more than you should, it’s time to request an expert shipping assessment from Unishippers!
Consider a shipping assessment from Unishippers a complete physical for one of the most vital parts of your business health. International delivery of Q-interactive starter kits includes a shipping and handling charge of $25 per kit.
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Please only click submit once. When your request has processed you will be brought to a confirmation page. Assessment 3 Buyer: The Theatre of Wine, in Greenwich, London, United Kingdom Shipowners/Shippers: Carry Carefully, South Africa The copy of B/L is attached.
A. 1. for the carriage of a consignment of wine from South Africa (which has incorporated the Hague-Visby Rules, under its own Carriage of Goods by Sea Act ) to London (the UK).