Pharmaceutical Logistics & Distribution

White Paper

Leading Minds Seminar Post Event Report, Discussion Findings & Practitioners Suggestions for Change

The second Leading Minds Seminar covered a range of topics including MHRA inspectorates feedback on GDPs for APIs, implementing a global data monitoring system, CRT policy, transport qualification and more. Read the report in 10 minutes, and take away the best points from 8 hours of great community forum discussions.
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GDP for APIs New Regulations

APIs, drug substances, starting materials or excipients… any name you give them, are now under strict GDP regulations to handle carefully, within temperature specification from the point of manufacturing at the API plant. This article will discuss 2015 bottom-line regulatory requirements for API suppliers and manufacturers – and what pharma manufacturers can do to ensure procurement of quality materials.
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How to Implement a Temperature Excursion Allowance Model Using Multi-Level Data Loggers

Allowing excursions reduces QA resources and product release time. Temperature monitoring can be seen as yet another process to get under control for pharmaceutical shipments, and at times some companies want the easiest solution. Pick a high/low data logger off the shelf and throw it in the box.
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Transitioning to the Modern World of Data Monitoring and Analysis

Processing excursions and conducting quality investigations use extensive resources. Ineffective data handling processes can take so much time, some companies never get to value add activities such as trending cold chain data. Today, with the cost-effective technology available, that should never be the case. So why isn’t every pharmaceutical company using a state-of-the-art data monitoring system with advanced reporting and analytics capabilities?
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Understanding New Data Integrity Regulations for Temperature Controlled Pharmaceutical Supply Chains

Amidst increasing concerns over data integrity, the UK MHRA has released new guidance that reflects FDA and other global requirements for data storage, access control and audit trail in GMP environments. The MHRA has gone further to define what this means for temperature controlled pharmaceuticals, including recommended use of data loggers and download processes at destination. This article will also talk through data monitoring technology that may…or may not enable your compliance.
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Losing Everything: Is a Chart Recorder Enough to Protect Critical Assets?

Environmental / temperature monitoring plays a vital role in the manufacturing (cGMP) and healthcare (JCAHO, CAP, USP 797) markets. In the event of a temperature excursion, do you know if your product is still acceptable? Would you lose valuable product or days worth of testing time?
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Stability Budget: Data the Superhero

Only an estimated 30% of pharmaceutical companies use a stability budget to manage TOR time for their products. However, it’s agreed by most practitioners that it’s a useful tool, once set up. This article discusses different approaches to setting up and managing a stability budget. By adding up each ‘leg’ of a cold chain from API through to patient, a stability budget can help expedite decisions if a medicinal product is safe to be consumed.
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Central Monitoring Systems 101: Easier Management and Better Control of Critical Assets

A central monitoring system provides a solution for automated continuous monitoring. It will enable your facility to have fast, standardized responses to alarms and efficient, electronic reporting capabilities, adding a superior level of protection for your irreplaceable products. 
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Transitioning to an Enterprise-CMS (Environmental Monitoring System) in a Regulated Environment

If your facility is growing or has come under the purview of GxP regulatory review, you know that data is the critical for healthcare facilities like hospitals to comply with JCAHO or Pharma to comply with FDA 21 CFR 11. Regulators want to see evidence that demonstrates maintenance of correct environmental conditions for healthcare related materials and products being stored in a facility.
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Warehouse Mapping of GxP Storage Facilities: Why it’s Not an Option

When your warehouse stores temperature sensitive pharmaceuticals and life science products, a top of the line HVAC system with carefully placed thermostats is not enough to ensure product quality and consumer safety. Why? It is the nature of warehouse facilities, no matter the size, to experience temperature gradients.
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Case Study


Endocyte is a biopharmaceutical company seeking to maximize the potential of small molecule drug conjugates (SMDCs) with companion imaging agents. Endocyte has a large network of 53 monitoring points that requires a regulatory compliant central monitoring system that enables them to react to alarms quickly and give complete insight to all labs and equipment storing their irreplaceable materials.
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A cold chain monitoring solution that streamlined end to end processes ensuring successful clinical trial progression and cost-effectiveness.
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Site Monitoring Kit

No more daily manual temperature inspections and paper min / max lists which are unreliable and difficult to archive. One brief check once a week and one monthly download is all the site staff needs to do.
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