Quality
To control and ensure the excellence of our medicines, our Quality area is responsible for the entire manufacturing chain, which ranges from supplier qualification to the response to customer service center outreaches.
In addition, there are other important controls to guarantee the quality of the products, which consist of:
International quality standards that go beyond local requirements
We conduct periodic audits of our factory with Amgen's Global Quality team to ensure the same standards around the world.
We maintain a continuous global surveillance process that monitors all suppliers involved in our production chain to ensure compliance with all requirements of regulatory agencies and markets in which we operate.
Audits
Assessment of the company's internal controls to prove the quality of the processes, confirm regulatory compliance and identify improvements that can be adopted in the procedures. These assessments are conducted by Amgen's global Quality team, which periodically visits manufacturing plants around the world to ensure that the processes are the same in all countries.
Supplier qualification
The choice and maintenance of our suppliers depends on rigorous and frequent audits to guarantee the quality standard we demand. Our teams visit all suppliers in loco prior to their homologation. Equipment qualification: proves that the equipment is working correctly and delivers the proper results.
Quality Control
Analyses are performed with random samples of the products that will be distributed to market to ensure they meet the specifications. This control covers physical-chemical and microbiological analysis.
Stability
It demonstrates that the product maintains, within the specified limits and throughout the period of storage, transport and use, the same characteristics that it had at the time of its production.
Environmental Monitoring
It is the control of viable and non-viable air particles present in the work environment and on surfaces, as well as in the employees who perform activities in the area. This monitoring guarantees and assures the necessary microbiological conditions to certify the quality of the area and prove that the release of our products is in accordance with current legislation.
Cleaning validation
Evidence that the approved cleaning procedure removes residue from previous products, residue from cleaning agents and also reduces the microbial load present on equipment to a level below than the established as safe, so we do not generate contamination of products that will pass through the equipment next.
Process validation
Evidence that a process, operated within pre-established parameters, can be performed and reproduced effectively and safely for the medicine manufacturing within the specifications and quality attributes of this product.
The importance of this concern about Quality and our constant evolution generates improvements that guarantee greater agility in our processes, success in regulatory audits and support our submissions of new records.
In line with all this control of the production chain, Bergamo follows international quality standards, through a quality system integrated with Amgen Global. About that, we highlight:
