Certifications

certifications

Guna S.p.a. has obtained the ISO 9001:2008 – ISO 13485:2012 certification

Guna has started to optimize the production processes and is pleased to announce that the effort to implement a “high quality” management was successful.

The quality of the production processes has improved thanks to the “Quality Certification of all activities performed by GUNA“.

Since Guna complies every day with the requirements of Good Manufacturing Practice, it has obtained the UNI EN ISO 9001: 2008 Quality Management Systems regarding the processes listed below:

  • Design, Production and Marketing of Homeopathic medicaments and Dietary supplements, Cosmetics and Medical devices;
  • Design, Drafting, Editing and Marketing of editorial products;
  • Organization and supply of educational events in the medical-scientific field.

Design includes all the steps of Research and Development.

GUNA has also obtained the UNI CEI EN ISO 13485: 2012 Medical Devices-Quality Management Systems certification for the processes listed below:

Production and Marketing of Medical Devices for injectable application and for application to mucous membranes.

PRODUCTION

G.M.P., Good Manufacturing Practice Certification

GUNA products are manufactured according to the highest quality standards, in strict compliance with Good Manufacturing Practice. The manufacturing technologies used at GUNA laboratories are improving more and more. Guna uses risk management tools so as to integrate quality systems with the regulations of Good Manufacturing Practice in order to boost innovation in terms of production and technology.

QUALITY ASSURANCE AND CONTROL

GUNA targets and daily challenges

The crucial factors for GUNA success are high quality standards, environmental protection and safety and customer focus. A wide Integrated Quality Management System ensures compliance with all applicable international regulations and helps improve product quality and optimize processes while respecting health, safety and environmental aspects.

Control of all the substances used

With the aid of control methods in compliance with Good Manufacturing Practice, all raw materials and other ingredients, finished products and packaging materials are subjected to Quality Control who, before authorizing their use, examines the purity, the composition, the expiration date, compliance with international and/or national standards. This procedure is particularly crucial when using ingredients of natural origin, the use of which must necessarily be regulated to ensure a constant and good quality level. The leaders of the “Quality Assurance System” support GUNA worldwide to ensure the high quality of its products. They also ensure the compliance to standard procedures and the application of international regulations.

Supplier Code of Business Ethics

GUNA quality management System provides for a specific procedure for 

Selection and assessment of Suppliers that provides the requirements and the characteristics that they must have, with a special focus on those Suppliers who have a direct impact on the quality of the product, i.e., the Suppliers of raw materials, packaging material and Subcontractors.

To support this procedure, GUNA has also drawn up a “Supplier Code of Business Ethics” to which they must conform so as to establish a proactive partnership – with possible tutoring by GUNA – in order to maintain a “top quality network” from the beginning to the end of the processes performed.

Click here to read the text of the “Supplier Code of Business Ethics”.

Guna’s commitment towards patients

Our staff knows they have a dual responsibility. On the one hand, the quality of the products should be managed according to the needs of patients and physicians. On the other hand, we must always follow strictly the regulations of the pharmaceutical industry. 

This is the reason why GUNA applies a daily Quality Management Policy in accordance with the requirements of Good Manufacturing Practice and International Quality Management Systems confirmed and certified in the UNI EN ISO 9001: 2008.

The aforementioned task does not involve only a huge responsibility, but also helps GUNA to maintain its constant success over time.