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Merak stores your laboratory archives in accordance with the applicable regulations and standards

Optimum climatological conditions Optimum climatological conditions

In accordance with strict regulations In accordance with strict regulations

Maximum <br/>flexibility Maximum
flexibility

Emergency generators and backup systems Emergency generators and backup systems

GDP <br> permit issued by FAMHP GDP
permit issued by FAMHP

Archiving samples and reference materials require intensive maintenance and large amounts of space and energy. The legal retention period of your laboratory archives can amount to ten years after the product is taken off the market. During this period, Merak will store your material under optimum conditions and in accordance with the strictest regulations. In this way you do not take any risks.

Merak stores your data in a suitable environment.

Ultra-low temperature freezers (ULT):
In specially built laboratory archives, Merak has ultra-low temperature freezers able to cool your data down to -86°C. Due to the extensive safety measures, the ULT freezers are always on standby.

Calibrated and independent data loggers:
These specialised data meters send their results to automated climate-control systems. In this way, temperature and humidity are always maintained. They also backup their results in a secured safe. And if something should still go wrong, the backup freezer ensures the continuity of the storage of your material.

Merak offers you the correct equipment.

Good Distribution Practice of Medicinal Products for Human Use (GDP). Permit issued by the Federal Agency for Medicines and Health Products (FAMHP)
Legal basis:

  • in accordance with the requirements of article 77 of Directive 2001/83/EC (see permit), GDP is a global guideline for the correct distribution of medicinal products for human use;
  • has had a legal basis in Belgium since 14/12/2006.
Merak can assist you:
  • Because the non-commercial stock must be kept separately from the commercial stock.
  • A GDP permit (obtained via the FAMHP) is required for storage (warehousing) (permit first obtained by Merak in 2011).
  • As a result, you can archive medicine samples with Merak.
  • GDP covers the distribution of medicines under the right conditions (packaging, temperature during both storage and transport). In this respect, Merak makes use of climate-controlled transport, special storage areas and permanent monitoring.
Storage: in practice:
  • Dust filters up to 0.5 microns to protect the room from minor dust contamination
  • A specific zone for incoming and outgoing archives (Inbound vs Outbound zone)
  • Storage in specially-developed boxes (the customer is responsible for packaging medicines and health products)
  • Storage per:
    • Type of product (no incompatible products stored together)
    • Permanent temperature monitoring
    • Climate-controlled transport
    • Returned, recalled or rejected product - PMT zone

Seamless procedures:
An anonymous barcode system registers each scan and remembers the exact storage location of your data carriers. In this way your data is always traceable. And because you decide who will have access to your laboratory archives, it will not get into the hands of unauthorised people.

At Merak we provide you with a complete service.

A certified approach:
Merak has all the key certificates for your laboratory archives. The infrastructure and working methods are in accordance with the OESO regulations, Good Laboratory Practice (GLP) guidelines, CBMT terms and conditions, Vlarem I and II legislation and Codex. We guarantee a correct handling of your laboratory archives.

Merak Inventory Online:
With this online application you can retrieve your material through a secured internet connection. With a few clicks in the inventory you can request samples which our couriers will deliver to you. Through this simple management system you can also add or remove data from samples. In this way your archives only contain relevant information.

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