I have worked as a QA since early 1990s in GLP and GCP areas when I started to work in a Finnish pharmaceutical company. Back then different pharmaceutical development processes were still mainly made by the company itself by using its own resources. Since then, the research work has become increasingly outsourced also changing the work of quality management and QA.
“Ever since the start of the early pharmaceutical development, the basic need has remained the same: our products must be ethical, safe, effective, and reliable. This will be my guideline as your partner.”
Understanding of Different Processes from Company Perspectives
Since the beginning of 2000 I was responsible for the whole QA process in a small pharmaceutical development company. By then the whole pharmaceutical development process came clear starting from API manufacturing process ending to statistical reporting of a clinical trial.
I have also worked for a couple of consulting companies, in one of which ISO 9000 was implemented. As a consultant I evaluated customer’s quality management systems, acted as an outsourced QA and gave training in various occasions among others.
As a representative of site management organization, I managed and trained clinical trial teams. I also negotiated contracts and budgets and managed invoicing process. Different perspective to clinical trials was also experienced later as a sponsor’s trial manager.
Because I am QA from my heart, after some years I came back to QA function where I acted as a QA in a CRO before starting as a consultant in Qualidea.
Understanding of Entities to Find the Right Quality Strategy
We are now living in a world with a vast number of different actors since development projects, manufacturing processes, and trials are conducted in many countries across the world. The whole field has changed for example through numerous digital innovations. There are units that are specialized to do certain parts of our research process or a trial almost automatically.
How can we be sure that our trial is conducted with a reasonable level of attention and quality? How can we get the assurance that every single piece is relevant and traceable? There may be practical differences that vary from different cultures. There might also be different interpretations about quality aspects between the people within one company. Moreover there is pressure to make the right decisions faster but with equal requirements.
Nevertheless, behind all the complexity, the core has stayed the same. QA has to get the assurance that every individual knows what to do. QA has to get the assurance that a single analysis, test, study, or trial is valid and traceable in order to get valid results and safe products. Ever since the start of the early pharmaceutical development, the basic need has remained the same: our products must be ethical, safe, effective, and reliable. This will be my guideline as your partner.