1. What activities are performed in the Quality Unit?
Two groups are part of Quality Unit: Quality Assurance e Quality Control.
The main responsibility of Quality Assurance is to be involved in all quality-related matters. Thus, Quality Assurance ensures that all the processes involved, directly or indirectly, in the manufacture and control of APIs are conducted within predefined acceptance criteria in line with Health Authorities requirements. Thus, potential bad impacts of those processes on the product quality are prevented, monitored and properly managed.
Few members of the Quality Unit are Qualified Person, which means that they must release or reject the batches produced.
Quality Unit is the interface of the company with National Regulatory Authorities and point of contact with customers Regulatory offices.
2. What is the activity carried out by Quality Control?
Quality Control is dedicated to the analysis of all incoming goods to be used in Production, Intermediates and Finished Products manufactured in the site. Also stability studies on the manufactured APIs are performed in the laboratory, such as validation of the analytical methods used. Moreover, the personnel of QC lab is involved in the IPC (In Process Control) to be performed in order to strictly monitor the manufacturing processes.
3. What quality controls are required before an active ingredient is placed on the market?
Every API (Active Pharmaceutical Ingredient) must comply with a series of regulatory requirement before being put on the market. First of all it must complies with relevant Pharmacopoeial monographs (a list of test with related limits) and it must be manufactured according to GMP (Good Manufacturing Practises). If both requirement are fulfilled, the request to approve the site as manufacturer of the API must be submitted to Regulatory Authorities together with a Drug Master File (DMF). The DMF describes all the activities performed in the site regarding each API (e.g. the manufacturing process, the analytical controls, the stability studies. Health Authorities then authorize the manufacturing of the API.
4. List three adjectives that you think describe SUANFARMA Italia.
Lean, dynamic, well organized company, team building focused. One company – one target – one team is our motto.
5. What and how many certifications do you currently hold and with which authorities?
We are authorized to produce veterinary APIs by Italian Ministery of Health and human APIs by Agenzia Italiana del Farmaco (AIFA). Furthermore we are allowed to market our product in the US market, since being inspected in the past by FDA.