Our Cold Chain Professional Services was created to assist the pharmaceutical, life-science, blood product and food service industries’ demand for practical and operational assistance in conforming to GDP and cold chain requirements. We offer unique and specialist services focusing on the operational requirements of temperature-sensitive supply chains.
Globally, there is an increased focus by all regulators and health service providers to ensure temperature sensitive products are transported in accordance with GDP and product temperature requirements.
M2 Management Solutions combine skills and experience in logistics, temperature measurement, qualification, mapping, cold chain packaging, refrigeration and GDP to provide invaluable cold chain knowledge. We are here to assist with the demand for temperature sensitive supply chain optimization, qualification, validation and regulatory compliance.
We are specialists in cold chain and temperature sensitive logistics for the pharmaceutical, life sciences, blood product, and food services industries..
Our Point of Difference
We implement and apply practical knowledge to meet GDP requirements.
We are Subject Matter Experts/Specialist/Engineers/Designers.
We design, customize and implement Engineering Solutions.
We highlight and resolve our customer’s problems to comply with their internal and regulatory requirements.
Consulting
M2 Management Solutions have extensive experience in all aspects of Cold Chain Temperature Monitoring, Distribution and Logistics.
Cold chain is a highly specialized area with over 70 variables which impact the maintaining of temperature within the supply chain. The complexities of cold chain are often overlooked within companies creating temperature excursions.
To meet the growing cold chain challenges, M2 Management provide exceptional expertise in identifying critical areas where excursions occur. A well designed and qualified temperature supply chain reduces excursion, cost and risk. An efficient designed supply chain validated using GDP process validation methods delivers on time in temperature deliveries.
M2 Management Solutions understand the complexities of each stage of logistics and distribution from manufacturing to patient. Our extensive expertise has us working throughout many industry segments. We use a practical approach to understand our customer’s main needs and requirements, depending on their products, type of business and location on the supply chain of temperature sensitive products has placed us in a competitive advantage against other companies. Our consulting services are designed to attend the current challenges that regulators are reinforcing to each of the actors of the supply chain and they can be customized to be align with your requirements and strategic objectives
Auditing
M2 Management staff have vast knowledge and experience of all the variables that impact a temperature-sensitive supply chain. Our expertise and services have been utilized by many of the world's largest pharmaceutical, life-science, blood product and food service industries.
M2 Management conduct on-site audits and reviews of the client's cold chain. This involves a comprehensive analysis of the whole distribution chain, current methods, operational processes and other key elements to establish a base line to identify risks, areas for improvement and cost reductions.
At this time there is no specific legislation around the globe for shipping cold chain and temperature-sensitive products and it is generally covered by various guidelines and conformance to GDP. M2 Management Solutions find documentation and auditing specifically relating to temperature is often overlooked. The regulators are consistently taking the view that the products are required to be shipped in accordance with temperatures specified on the product labelling (i.e. conformance to label). In some cases, they have even commented that stability data should only be used as a release mechanism for occasional out of specification shipments, or for the benefit of the end consumer and not used as a justification to release all shipments.
Many regulators are requesting to see documentation relating to the delivery of temperature-sensitive goods during audits. Temperature-sensitive goods are receiving more attention every year. Cold chain +02°C to +08°C products, and products required to be stored below +25°C and +30°C require the same level of conformance in order to meet GDP.
Temperature excursions can affect product’s efficacy, leading companies to incur in major costs if quarantine and product recalls must be performed. Representing an ongoing risk to patient safety. More legal cases are appearing where proof of delivery in temperature is being used as a mechanism to secure compensation claims. Without a validated supply chain, it is difficult to defend a claim.
M2 Management Solutions audit reports provide a company with a base to implement an action plan to resolve critical problems and prepare documentation specifically relating to cold chain and temperature-sensitive logistics. A cold chain audit from an operational perspective will identify gaps, non-conformances and potential high risks. Our in-depth review of the operational process within a company inevitably highlights major issues which are often not identified by normal internal audits. We provide an assessment on your current operations via a GDP – GAP Analysis Audit, followed by a full audit report and recommendations. M2 Management Solutions provide recommendations identifying risks and gaps in documentation. Recommendations on conducting regular temperature auditing and operational qualification processes to achieve a robust, properly qualified supply chain for temperature-sensitive products.
M2 Management have conducted extensive auditing for companies throughout the United States. Management are surprised at the large number of unidentified failures, gaps and critical excursions within companies supply chains as a result of the M2 Management comprehensive auditing process, making sure the results are accurate and reliable to increase your business efficiency.
Optimization
We can design an end-to-end integration and plan for your cold chain/temperature supply chain. This will include an assessment on your current operations via a GAP Analysis Audit, followed by a full audit report and recommendations.
We perform audits on site, together with the process owners, making sure the results are accurate and reliable to increase your business efficiency.
Design
Cold Chain practices have generally evolved over many years driven by demand, expansion and new products. Re-occurring problems have been resolved by implementing new procedures within the supply chain. As a result, we find many supply chains have become overly complex, inefficient and costly. M2 Management Solutions specializes in designing streamlined, efficient temperature monitoring solutions that remove complexity and reduce overall cost. A properly designed temperature monitoring solution will minimize excursion and exceed GDP requirements. M2 Management Solutions have studied the temperature supply chain process at operational level and identified the key elements which determine the successful outcome.