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Recertification audit, related to quality management system, was held on July 7th 2017. Amsal Pharmaceuticals d.o.o. Sarajevo was succesfully certificated, according to requests of ISO 9001:2015 standard.
In accordance to ISO 9001:2015 standard, Amsal Pharmaceuticals determined:
After conducted inspection survey of primary packaging of solid oral forms, secondary packaging of medications, releasing medication batch and chemical-physical testings, it has been determined that Amsal Pharmaceuticals is following principles of good manufactoring practice (GMP) for medications, which is confirmed by Certificate for conducting a good manufactoring practice for medicinal products , No: BH 905-15 INS GMP 06-01/15, dated 30.03.2015.
Based on gained results, the Ministry issued a Decision of fulfilling of conditions for extention of Permit for secondary packaging of medicinal products, quality control and product batch release for: semisold, liquid, parenteral, vaginal and rectal products and powders.
Objectives of the Congress were to promote the universal values of unity and multidisciplinary approach to the food manufacturing, it's hygiene status and quality, different nutrition methods as well as possible implications to the human.
Students of medical, humanistic, natural and mathematical and bio-technical sciences took part in Congress organization. Main topics included following areas:
1. Primary food manufacturing and food processing
2. Additives in food industry
3. Toxicology and food safety
4. Modern diagnostics and food analysis
5. Nutrition during a life cycle
6. Diet therapy
7. Biotechnology in human nutrition
8. Organic and traditional food
Students of other universities from Bosnia and Herzegovina, as well as students of neighboring countries, also took part of this Congress.
Amsal Pharmaceuticals d.o.o. Sarajevo was succesfully certificated, according to requests of ISO 9001:2008 standard.
In accordance to ISO 9001:2008 standard, Amsal Pharmaceuticals determined:
– Quality policy and objectives,
– The processes necessary for QMS (quality management system),
– Documents necessary for effective planning, implementation and management processes,
– The necessary resources for monitoring, measurement and analysis, and continuous improvement.
Since October 2015, Amsal products can finally be found in the pharmacies on the Kosovo market.
Export to Kosovo presents continued expansion to the regional markets.
The competent authority of Bosnia and Herzegovina, Agency for Medicinal Products and Medical Devices, performed an inspection in Amsal Pharmaceuticals Ltd. Sarajevo, in accordance with the Law on Medicines and Medical Devices (Official Gazette of BiH, No. 58/08), the Ordinance on the manner of conducting the inspection control (” Official Gazette of BiH ”, No. 23/11) and the Ordinance on good manufacturing practice for medicinal products (Official Gazette of BiH, No. 24/10).
Based on the findings, collected during the inspection, performed from 18th through 20th of February, 2015, it was found that Amsal Pharmaceuticals d.o.o. Sarajevo complied the principles of good manufacturing practice (GMP) for medicinal products, which was certified by Certificate of GMP compliance of a manufacturer, under number: BH 905-15 INS GMP 06-01/15, dated of March 30, 2015.
– Quality policy and objectives,
– The processes necessary for QMS (quality management system),
– Documents necessary for effective planning, implementation and management processes,
– The necessary resources for monitoring, measurement and analysis, and continuous improvement.
After the certification audit of quality management system held on 17 July 2014, Amsal Pharmaceuticals d.o.o. Sarajevo is certified according to standard requirements of ISO 9001: 2008.
Candidates who become members of the Amsal Pharmaceuticals team will have the opportunity of continuous training, professional development and promotion within the company.