Tutela Medical

Comprehensive Monitoring Systems for Life Sciences

Tutela Medical

EC publishes new guidelines for distribution of medicinal products

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On the 7th March 2013, the The Guidelines on the Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01) were issued by the European Commission. The revised guidelines enter into force September 7th 2013.

Here are some useful excerpts
“It is the responsibility of the supplying wholesale distributor to protect medicinal products against breakage, adulteration and theft, and to ensure that temperature conditions are maintained within acceptable limits during transport. Regardless of the mode of transport, it should be possible to demonstrate that the medicines have not been exposed to conditions that may compromise their quality and integrity. A risk based approach should be utilised when planning transportation.”

The required storage conditions for medicinal products should be maintained during transportation within the defined limits as described by the manufacturers or on the outer packaging.

  • If a deviation such as temperature excursion or product damage has occurred during transportation, this should be reported to the distributor and recipient of the affected medicinal products. A procedure should also be in place for investigating and handling temperature excursions.
  • Risk assessment of delivery routes should be used to determine where temperature controls are required. Equipment used for temperature monitoring during transport within vehicles and/or containers, should be maintained and calibrated at regular intervals at least once a year.
  • Dedicated vehicles and equipment should be used, where possible, when handling medicinal products. Where non-dedicated vehicles and equipment are used procedures should be in place to ensure that the quality of the medicinal product will not be compromised.
  • Where transportation is performed by a third party, the contract in place should encompass the requirements of Chapter 7. Transporters should be made aware by the wholesale distributor of the relevant transport conditions applicable to the consignment. Where the transportation route includes unloading and reloading or transit storage at a transportation hub, particular attention should be paid to temperature monitoring, cleanliness and the security of any intermediate storage facilities.
  • Provision should be made to minimise the duration of temporary storage while awaiting the next stage of the transportation route.
“Containers should bear labels providing sufficient information on handling and storage requirements and precautions to ensure that the products are properly handled and secured at all times. The containers should enable identification of the contents of the containers and the source.”
For more information, follow this link to a downloadable PDF.

Tutela strengthens UK Technical Team

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Tutela Monitoring Systems, the world’s leading provider of monitoring systems, appoints Aaron Ball as Service Technician

Aaron Ball joins Tutela as a service technician at a time when the company is rapidly growing. Aaron will be field based, helping the installation engineers by calibrating and servicing the Tutela products across the UK. He will also help with installation of  Tutela Wireless Monitoring Systems on the larger sites.

Aaron comes to Tutela having previously worked for a high precision, ISO:9001 Company, assembling a range of DC motors and stepper motor drivers, and he has recently completed an HNC in electronic engineering. He hopes to use this knowledge and experience in this role to ensure that Tutela continues to grow and still provide high class customer service.

Aaron commented “Tutela is a fast growing company that I am very grateful to be a part of at such an exciting time. I am looking forward to meeting the customers at the different sites, and maintaining a strong relationship with them. I am looking forward to the challenges that will be presented to me, and trust that Tutela will help develop my skills.”

Visit the website for more information on Tutela Monitoring Systems

About Tutela Monitoring Systems

Tutela Monitoring Systems (Farnborough Hampshire) supply and install fully validated and compliant web-based, monitoring and recording systems for Pharmaceutical, Biotechnology, Academic & Clinical Research, Laboratories & Blood Banks worldwide.

Tutela Monitoring Systems are part of Next Control Systems, an ISO9001:2008 company that has been successfully marketing web-based medical monitoring and recording systems worldwide for over 20 years.

For more information, contact:

Tutela Monitoring Systems

MHRA Compliance ‘The UK regulatory landscape in 2013

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Meet Tutela at the London Regenerative Medicine Network Meeting with the MHRA 4th April 2013

‘The UK regulatory landscape in 2013′

 The meeting will discuss the evolving regulatory landscape for medical products and its implications on MHRA compliance.
Room 501/502, 5th floor at the MHRA Headquarters, 151 Buckingham Palace Road, Victoria, London, SW1W 9SZ
Tutela are providers of MHRA compliant temperature monitoring systems for medical facilities.

 

Contact Zoe Adams for more information or to arrange to meet at the symposium.

For more information about the meeting, please visit the website.

Tutela Welcomes ImmunoTek BioCenters

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Tampa, Florida – August 4, 2014 – ImmunoTek BioCenters, a plasma collection organization, has chosen Tutela Medical as the provider for their temperature monitoring needs. ImmunoTek collects human blood plasma and operates multiple collection sites throughout the Southeast.

ImmunoTek will use the Tutela customisable dashboard enables them to view multiple facilities all in one screen, showing any data they need. Our customizable software and cloud-based platform benefits any organization that has multiple locations and it provides all of the necessary compliance documentation required by the FDA.

ImmunoTek joins the ranks of other top medical product and healthcare clients like Biotest Pharmaceutical, Gen Probe, Sloan Kettering, Grifols Plasma, and The University of Miami Tissue Bank.

Tutela Monitoring Systems, LLC is a division of ‘Next Controls Systems’ providing temperature monitoring solutions in North America and Europe.

Contact:

Jennifer Dickmann

[email protected]

14930 N. Florida Ave.

Tampa, FL 33613

414-690-3615

Join Tutela at the HCP Spring Conference 2014

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Tutela will be attending the Health Connect Hospital Pharmacy Spring Conference, May 5-7  in ST Louis, MO.  The conference promises to be a high intensity mix of :

  • Peer networking amongst up to 250 Hospital Pharmacy Directors from America’s most prestigious hospitals and health systems.
  • Accredited educational sessions to assist in expanding your industry intelligence
  • Innovative solutions for management of pharmacy departments

The Conference is located in central Atlanta at Hyatt Regency St. Louis at The Arch, St. Louis, MO.

For more information and registration, please follow this link.

For more information about Tutela Monitoring Systems click here.