Your partner in Certification and Batch release 

Certification and batch release

The building and facilities on Michalovská street 2 in Košice that are designated for the manufacturing of intermediate products and pharmaceuticals in the stage of analytical inspection, quarantine and release of batches of pharmaceuticals to EU market, are located and designed in a way to enable operation in dependence on the type and phase of production, cleaning and maintenance according to conditions granted by GMP certificate. The facilities are designed in a way to minimize in a maximum level any possible contamination. The facilities enable proper restriction of contacts with microbiological contaminants in case when for the intermediate products or medicaments are prescribed microbiological specifications. The size of facility enables well arranged placement of the devices and material and also the flow of material – medicaments and the staff is well organized to prevent any faulty change and contamination of already released intermediate products and medicaments.

 

There are available reserved spaces for activities that precede the proper release of intermediate products and medicaments.

 

Among our activities related to Batch certification and product release belong as follows:

  • acceptance, identification, sample taking and quarantine of input materials that await release or refusal,
  • quarantine before release or refusal of intermediate products and pharmaceuticals
  • sample taking of intermediate products and pharmaceuticals, subsequent analytical control
  • retaining of refused materials up to further instructions (e.g. return, repeated processing or disposal of waste of various categories made by a contracting firm)
  • archiving of retention and referential samples of released batches 
  • storage and distribution of released products to the targeting market.

Contact us

 

GRAMM spol. s r.o.

Masarykova 17

040 01 Košice

 

Office:

Michalovská 2

040 10 Košice

Tel./Fax: +421556337430

E-mail: info@gramm.sk

 


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