Which certifications does Merak have?

ISO 9001

This is a standard setting out the requirements for the quality control system of an organisation and the manner in which the organisation deals with the quality control policy. For instance, the quality control policy must be set out in writing and communicated to the employees. The organisation must ensure that customers are satisfied by fulfilling the requirements of customers and the applicable legal regulations. The operating processes must be recorded in a quality control manual and these processes must be adhered to.

ISO/IEC 27001

This is an ISO standard for information security published in October 2005. The standard specifies the requirements for identifying, implementing, executing, checking, assessing, maintaining and improving a documented Information Security Management System (ISMS) in the framework of the general operational risks for the organisation. The standard specifies the requirements for the implementation of security measures adapted to the needs of the individual organisations or parts thereof. The ISMS is designed to guarantee the choice of adequate and proportional security measures, protecting the information and giving interested parties the required confidence.

ISO 14001

The ISO 14001 standard is an internationally accepted standard setting out the requirements to be met by an efficient environmental management system. For instance, the environmental impact of our activities and services must be identified and verified. It is also requires that continued efforts are made to improve the environmental management and to implement and achieve a systematic approach to setting out environmental objectives, and to announce when these objectives are achieved. Merak additionally pays great attention to observing regulations, improving its environmental performance, its external communication and the involvement of employees.

GDP

Good Distribution Practice of Medicinal Products for Human Use
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