Quality

Quality guaranteed

Quality assurance is our overriding concern in the ongoing review of our processes and control procedures. Internal and external audits are performed on a regular basis. Quality guides our human resources management, with skills and values as o top priority.

GMP

Good manufacturing practice

This refers to the quality control of manufacturing for foods, pharmaceutical products and medical devices (Wikipedia). GMPs are guidelines that outline the aspects of production that would affect the quality of a product. Many countries have legislated that pharmaceutical and medicl device companies must follow GMP procedures, and have created their own guidelines that correspond with their legislation.

The GMP topics are implemented through Standard Operating Procedures (SOP’s).

All necessary Quality area’s are covered :

  • General requirements
  • Personnel
  • Quality Systems (changes, complaints, training, audits, deviations, validation, …)
  • Facilities and Warehousing
  • Equipment
  • Production controls
  • Finished product testing
  • Documentation and tracability

In Belgium the certificate is provided by the FAGG (Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten). It is the Belgian Federal Agency for Medicines and Health Products.

This agency also gave us the production license.

LABORATORIA SMEETS N.V.

Fotografielaan 42
B-2610 Antwerpen-Wilrijk
Tel. +32 (0)3 828 29 37
Fax +32 (0)3 830 21 36
e-mail: info@labosmeets.be

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CASE:  

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CASE: New Technology for API solubility  

In collaboration with the University of Ghent, Labo Smeets has realised a new process in pharmaceutical extrusion technology, which enables us to make highly soluble granules. The main application is to make pharmaceutical granule compositions to drastically improve water solubility of active ingredients. The technology is applicable for the following drug ...
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New Technology for API solubility

In collaboration with the University of Ghent, Labo Smeets has realised a new process in pharmaceutical extrusion technology, which enables us to make granules. The main application is to make pharmaceutical granule compositions to drastically improve water solubility of active ingredients. This equipment is installed and available since January 2011.

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CASE: Flexibility  

We were contacted by a company that had a large project based upon nasal therapy with essential oils. There was no supplier for the part, no clear definition of the product and no procedure lines to make the product, but there was a short deadline. Pressure in order to obtain the right information at the right timing. We agreed with the customer the precise ...
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CASE: Product innovation  

A customer identified a patented technology at one of the Belgian universities to make one of their products easier to administer. We were contacted at an early stage to help with developing the product. We jointly decided to set up a test manufacturing unit in order to produce small batches for the clinical trials. As the project outcome was uncertain, ...
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CASE: Strategic procurement  

One of  our pharmacuetical customers is a large consumer of raw materials. Often large pharmaceutical customers are constrained with their raw materials procurement strategies. The complexity of the regulatory filing for many of their products, prevents them from obtaining the best deal. Underlying causes are the intrinsic speed of action, but also the ...
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