How does the SUANFARMA Italia Analytical Laboratory handle testing and quality control processes? Raffaello Rimedio, Head of Analytical Laboratory & Services SUANFARMA Italia, tells us about it in this interview.
What does the Analytical Laboratory department of SUANFARMA Italia do?
The Analytical Laboratory department represents a novelty in the history of our plant. Historically, the analytical laboratory has always been under the responsibility of Quality Control, while today it has become a department in its own right, but which maintains synergies and links with QC, QA and the newborn R&D.
Suanfarma’s A.L. department is divided into chemical and microbiological, its main task being to test and verify the quality of intermediate and finished products so that established standards are maintained. Through chemical and microbiological analytical controls prescribed by the National and European Pharmacopoeia, commercial specifications or other provisions, it assesses that the products contain active ingredients that comply with the qualitative and quantitative composition stated in the marketing authorisation. The laboratory also inspects and tests incoming raw materials and packaging materials, performs analytical tests during the various stages of production to support statistical process control, and conducts environmental microbiological checks according to a predefined schedule.
Describe a typical day in your role
The laboratory is a crossroads of materials entering and leaving the plant, goods feeding our production departments and active ingredients destined for customers leaving. Every day the focus is on keeping to time. Allowing the flow to run smoothly, both in terms of the approval of raw materials and the release of finished products.
These include the scheduling of environmental controls, the planning of additional tests for validation, the analysis of products in stability or rather for the approval of raw materials from new suppliers or support tests for the R&D laboratory.
All these activities are the subject of our daily Flash Meetings where we prioritise activities, monitor the timing of analyses for finished products, discuss safety and laboratory maintenance. Last but not least, there are qualification schedules and planned maintenance of the instrumentation, whose state of well-being is crucial for the activities to proceed properly.
What complexities do you face in your work?
The greatest complexities I face are certainly linked to the novelty of a role that I have only held for a few months and for which I benefit from the support and valuable experience of my colleagues in QA and QU, as well as the professionalism and sense of responsibility of my new colleagues.
How has this job changed over the years?
It is difficult for me to say how this role has changed over the years. I have always seen the QC laboratory as a “customer”. What I can testify to is how my view of the plant has changed with the change in my role and thus shifting my point of observation. Production has a cadenced rhythm and moves at a sluggish pace, in the sense that when it changes gear or programme, as in the case of problems, it drags along and involves many adjacent departments. It is clear that production occupies a central position among the plant’s departments. Everything orbits around it, everything is needed for it to function, so from the inside the analysis laboratory appeared as one of the many satellites that revolved around it, serving as a well-aligned cog in the wheel of production activities.
Today I see things differently, I see all the effort, the commitment that is put into one of those ‘satellites’ on a daily basis so that the productive heart can beat properly. The rhythm of production becomes that of the laboratory, from the entry of raw materials to the analysis of the finished product, including process control analyses. The scheduling of activities such as the procurement of materials is done to allow the production programme to run smoothly.
Three words to describe SUANFARMA
In my opinion, SUANFARMA today is a group of people who want to work well together, and the three words which in my opinion best describe it are also a path to the future:
– Creativity (in)
– Change (in)