CONTACT SECTION
Quality Assurance
Product quality in Noventis s.r.o. is one of the fundamental requirements that accompany the entire production process. The company has long-term quality standards in place for the production of medicines and dietary supplements.
The basic requirement of all these systems is to produce a product of adequate quality, safety and efficiency. It does not involve mere final testing of the batch of each drug but also testing of the input raw materials, packaging, intermediates, and checking the entire production process with emphasis on the critical points. The production employees are regularly trained in the area of hygiene, sanitation and production procedures. The production and analytic procedures are checked within the validation process, critical equipment is subject to qualification (standard production check).
The system of GMP – Good Manufacturing Practice for medicines has been in place in Noventis s.r.o. since shortly after the establishment of the company. HACCP - a system of critical points and the control thereof the production process.
The Quality Assurance and Quality Control system is directly managed by the company management. Quality Assurance includes development of documentation systems, distribution and updating of documents, product releasing, monitoring of the quality parameters and the evaluation thereof in order to eliminate the deficiencies, if any. Quality Control includes laboratory activities – sampling, analysis of raw materials, products, etc.
A great advantage of our company is the direct connection and communication of all the responsible departments involved in quality aspects of each level of production and testing. The status of GMP is evaluated by means of regular internal audits.
The production and quality supervision authorities are:
- State Institute for Drug Control (SÚKL)
- Institute for State Control of Veterinary Biologicals and Medicines (ÚSKVBL)
- Czech Agriculture and Food Inspection Authority (SZPI)
Within the contract-based production of drugs and dietary supplements we guarantee the same system and conditions for the production and testing, and we are able to meet any other special requirements of our customers.
Certificate of GMP compliance of a manufacturer (human medicinal products).
Valid GMP certificate for the production of drugs covering:
- Production of non-aseptic products – soft gelatin capsules, tablets
- Quality Control – microbiological safety of non - aseptic products, chemical and physical analysis
