27 mar
press

Recertification audit

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:

  • 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.
  • A thorough risk analysis that enables the organization to set up activities that will prevent the occurrence of events that adversely affect the achievement of business goals
  • Analyzed customer satisfaction, which contributed to a better insight into the quality of service provided

 

27 mar
press

Agency for medicinal products and medical devices of Bosnia and Herzegovina visited Amsal Pharmaceuticals for a pharmaceutical inspection

Agency for medicinal products and medical devices of Bosnia and Herzegovina conducted a pharmaceutical inspection of Amsal Pharmaceuticals on 26th of February 2016, in accordance to Legislation of medicinal products and medical devices (”Official Herald of B&H, No. 58/08), Ordinance of inspection survey process (Official Herald of B&H, No 23/11) and Ordinance of medicinal products good manufactoring practice (Official Herald of B&H, No. 24/10).  

 

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.

27 mar
press

Federal Ministry of health visited Amsal Pharmaceuticals

Federal Ministry of health visited Amsal Pharmaceuticals on 4th of May 2016 in order to perform the inspection survey.

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.

27 mar
press

First student congress “Food-nutrition-health”

Amsal Pharmaceuticals, as a sponsor, participated in First student congress „Food-nutrition-health”. The congress was held for the first time and it took place at Sarajevo University, from July 7th to July 9th 2016.

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.

 

27 mar
press

Second certification audit

Second certification audit, related to quality management system, was held on June 6th 2016.

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.

 

27 mar
press

Certificate of GMP Compliance of a Manufacturer

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.

27 mar
press

The quality management system according to ISO 9001: 2008

Amsal Pharmaceuticals has, in compliance with the ISO 9001: 2008, 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.

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.

 

27 mar
press

Publication of job vacancies for Medical professional associates

THE COMPETITION IS CLOSED

In order to develop business activities, Amsal Pharmaceuticals invites applications for admission of Medical professional associates for promotion of our products in the Federation of BiH and the Republic of Srpska.

Candidates who become members of the Amsal Pharmaceuticals team will have the opportunity of continuous training, professional development and promotion within the company.

 

27 mar
press

The inspection of the Agency for medicinal products and medical devices of Bosnia and Herzegovina has approved business activities of Amsal Pharmaceuticals

On 5 and 6 June 2014, the Inspection of the Agency for medicinal products and medical devices of Bosnia and Herzegovina visited us and conducted a pharmaceutical inspection of the fulfillment of conditions to perform production of medicinal products.

After the completion of the inspection, ALMBiH issued the Decision No. 10-07.59-3197-1/14 of 12.06.2014 by which the firm Amsal Pharmaceuticals d.o.o. Sarajevo is authorized to perform production of medicinal products for the phases: primary and secondary packaging of medicinal products, quality control and product batch release.