CERTIFICATIONS
The company holds two major and recognized certificates. GMP within Good Manufacturing Practices in pharmaceutical production and manufacturing authorization for medicinal products issued by the State Institute for Drug Control
GMP certificate
GMP (just like the comparable ISO standards) is part of a system of quality assurance which ensures that products are consistently processed and inspected in accordance with quality standards, appropriate to their intended use, with an approved registration dossier for the particular medicine and other mandatory documentation. Good manufacturing practice applies both to production, and to quality control. Good manufacturing practice in pharmaceutical production, which like ISO standards deal with quality management, put emphasis on quality assurance and quality of manufactured products.
SÚKL certification
State Institute for Drug Control in the Czech Republic is the highest authority that approves and monitors the production of medicinal preparations. It issues certificates to operators certifies that they meet conditions of good manufacturing practice, and may decide to cancel the issued certificates in the case of non compliance or a breach of the law.
SÚKL issues a certificate of Good Manufacturing Practice to manufacturers of medicinal substances on their request, after meeting strict GMP conditions in full production. The certificate is valid as long as the company observes conditions upon which it has been issued.
