Tag Archive: Regulatory compliance

  1. Winter is Here: When and How to Conduct Seasonal Temperature Mapping.

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    As winter settles in and temperatures drop, it’s the perfect time to plan your winter temperature mapping exercises for areas where pharmaceutical products are stored. As per MHRA guidance, seasonal temperature mapping is critical for ensuring compliance and maintaining the integrity of temperature-sensitive products.  

    Let’s look at what temperature mapping involves, why it’s important, and how to execute it effectively this winter.

    What is Temperature Mapping?


    In essence, temperature mapping is the process of qualifying a storage environment to thoroughly understand the temperature variations experienced across the area. This is typically done by deploying temperature data loggers in a grid like pattern throughout the facility.

    • Duration: Data is typically collected over 7 to 14 days to account for fluctuations during working hours, nights and weekends.
    • Documentation: A detailed protocol and floor plan are developed before the exercise. These include the project scope and the exact placement of loggers.
    • Outcome: After data collection, a comprehensive report is created to:
    • Highlight facility performance.
    • Identify temperature excursions or deviations.
    • Recommend probe placement for permanent monitoring systems (a regulatory requirement).

    Why is This Important?


    • Regulatory Compliance: Temperature mapping ensures adherence to regulatory requirements and guidance such as the MHRA, EU GDP, WHO.
    • Facility Performance Assurance: Confirms storage areas are performing as expected, avoiding risks of temperature abuse.
    • Product Safety: Protects temperature-sensitive products from degradation due to poor storage conditions.

    How Often Should You Perform Temperature Mapping?

    Seasonal Mapping

    To meet regulatory standards and address environmental variations, mapping must be performed during both seasonal extremes:

    • Winter Mapping: Typically conducted between late November and early February. If your mapping exercise is due, now is the time to act!
    • Summer Mapping :  Typically conducted between July and August

    Requalification Intervals

    The frequency of temperature mapping depends on a risk-based approach, but here are some general guidelines:

    • Mapping for ambient areas is commonly repeated every three years with a regular Risk Assessment process
    • The Risk Assessment process should highlight any significant changes to the facility that may have an impact on performance, and could justify a requalification sooner than the 3 year period

    How Can Biomap Help?


    At Biomap, we specialize in temperature compliance services tailored to your needs:

    • Full Mapping Services: With expert engineers managing the entire project.
    • DIY Options: Hire calibrated loggers to complete the exercise independently.
    • Consulting Services: Guidance on regulatory requirements and optimization of storage conditions.
    • Permanent Monitoring Systems: Design and implementation to ensure ongoing compliance.

    Get Ready for Your Winter Mapping Exercise.


    Don’t wait for the chill to pass—plan your winter temperature mapping now to ensure your facilities remain compliant and your products are safe.

    Contact Biomap today for a no-obligation consultation or to schedule a site survey.

     

     

     

     

     

     

  2. GIRP Supply Chain Conference 2024 – 9th Edition

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    We are pleased to announce that our Director, Kane Edgeworth, will be a featured speaker at the GIRP Supply Chain Conference 2024, taking place from 14th to 15th October 2024 in Lisbon, Portugal..

    Kane will join an expert panel for a session focussing on “Transforming Digital Capabilities in the Temperature-Controlled Supply Chain,” a key theme in the rapidly evolving pharmaceutical and healthcare logistics sector.

    Presenting the possibility of a continuous mapping model vs the traditional methods in a session moderated by Mr John Preston, Director of Regulatory and Development, HDA UK.

    Transforming Digital Capabilities in the Temperature-Controlled Supply Chain.

    Speakers.

    • Mr Kane Edgeworth, Director, Biomap Ltd
    • Mr Alexandre Bosdonnat, Business Development Manager, Lainpharma
    • Ms Anni Svala, Quality Director, Tamro Finland, Vice-President, European Industrial Pharmacist Group
    • Mr Bruno Alves, Vaccines, Immunization, and Biological Products Unit, Directorate General of Health (DGS

    We look forward to Kane sharing his insights on how innovative digital tools and processes can enhance the efficiency and security of temperature-controlled supply chains.

    For more information and to see the full conference agenda, visit the official: https://scc.girp.eu/

     

  3. ECA Webinar: Temperature Sensitive Pharmaceuticals – Transport and Vehicle Qualification (Live Online Training)

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    On 10th of October 2024, join ECA Academy Live Webinar: Ensuring the Safe Transport of Temperature-Sensitive Pharmaceuticals. Co-hosted by Kane Edgeworth, Director at Biomap, and Peter Kralinger Founder of Carrymed. Hosted by ECA Academy.

    Are you responsible for the transport or handling of temperature-sensitive pharmaceuticals? Maintaining regulatory compliance and protecting product integrity during transportation is vital:

    Biomap invites you to a live, online training session, co-hosted by Kane Edgeworth (Director at Biomap) and Peter Kralinger (Founder of Carrymed), focusing on “Transport and Vehicle Qualification for Temperature-Sensitive Pharmaceuticals.” This webinar, hosted by ECA Academy, will provide an in-depth yet concise overview of regulatory expectations and best practices for the transport of products requiring special conditions:

    What You’ll Learn: Gain practical insights into the qualification processes for vehicles and transport systems designed specifically for temperature-sensitive pharmaceuticals. This training will help you ensure compliance and safeguard your cold chain logistics:

    • Regulatory requirements for transporting temperature-sensitive products
    • Step-by-step vehicle qualification processes
    • Best practices for maintaining product integrity during transit
    • Practical applications of qualification for cold chain transport

    Who Should Attend?: This session is ideal for professionals working in:

    • Quality Assurance
    • Validation
    • Engineering
    • Logistics
    • Cold Chain Management
    • Regulatory Compliance

    Click the link for more information on the Webinar: Temperature-Sensitive Pharmaceuticals – Transport and Vehicle Qualification