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Heerenveen, The Netherlands

Sharp’s Heerenveen facility provides both large-scale and specialised small-batch packaging capacity in shared or dedicated production suites. We offer expertise and capabilities in multiple specialist formats, with particular focus on vial labelling and packaging, as well as enabling access to the EU market through in-house QP services.

Our facility also offers a complete range of specialized cold chain packaging and labelling services for gene therapy products. A specialist infrastructure is in place including temperature and humidity controls and monitoring, and full -80°C freezer banks in shared or dedicated packaging suites.

Sharp Heerenveen holds also a European clinical services depot offering distribution and QP release services for investigational medicinal products (IMPs) in conjunction with our site in Rhymney, UK.

Facility Highlights

    • 8,500 m2 (92,100 ft2) facility including GMP production space, warehouse and offices
    • Ambient and refrigerated (2-8°C) packaging, storage, and distribution
    • Frozen (-80°C) storage and distribution
    • Shared and dedicated production areas
    • Controlled drug management
    • Manufacturing License for Wholesale Distribution Authorisation (WDA) and Investigational Medicinal Product (IMP)
    • Electronic Batch Record (EBR) generated via our Manufacturing Execution Systems (MES)
    • Gene therapy small-batch cold chain packaging suite
        • Optimal environment and specialist infrastructure
        • Dedicated HVAC air handling
        • Temperature and humidity controls and monitoring
        • Full -80°C freezer banks in dedicated production suite

Contract Services

Secondary packaging

Quality Accreditation

    • Regulated by Dutch Health and Youth Care Inspectorate (IGJ)
    • Ministry of Health of the Republic of Belarus – inspected
    • Ministry of Industry and Trade of the Russian Federation – inspected
    • Manufacturing License 108630F WDA 16273G
    • GMP certified

Contact

Neptunus 12
8448 CN Heerenveen
The Netherlands
Tel: +31 513 433 947
info@sharpservices.com

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