Vanesa García, Head of Quality Assurance at Asac Pharmaceutical Immunology gives us her point of view in the field of allergen and bacterial immunotherapy. She also talks about her day-to-day work in the technical department.
- What are your main functions within the Quality Assurance department of Asac Pharmaceutical Immunology?
As Quality Assurance Manager, my main role is to ensure a robust quality system that complies with current regulations. This translates into managing different tasks such as the training program, validation and qualification program, calibration and maintenance program, supplier management, data integrity, self-inspections, product quality review, etc.
In addition, we have a responsibility to promote our quality culture throughout the organization. Since it is the responsibility of the entire organization to comply with the quality standards set by the authorities and the company’s quality policy.
- What is the biggest challenge you have faced in the company?
Since the renovation carried out in 2017 in our facilities, we have had continuous and different challenges, mainly focused on positioning our products as a reference in different markets. This fact, has meant a continuous adaptation of our facilities and products to the requirements of different countries.
However, I can consider that the biggest challenge was to prepare our company to obtain the Authorization of the Spanish Health Authorities after the reform carried out. It was hard for all our technical area, as we needed to build and generate a new quality system, in our improved facilities.
- In terms of pharmaceuticals and quality, how do you keep up to date with the latest developments?
It is very important for us to always comply with the applicable regulations, and these are updated frequently. Therefore, we have to be continuously informed of changes in regulations, even before they are implemented, so that we can act in time when necessary.
Nowadays, we live in the digital era, where it is easier to be informed about any changes in regulations that will be applied. We conduct periodic reviews of each applicable regulation to ensure that we comply with the latest revision available.
- What regulations do you follow to ensure the effectiveness and stability of the drugs and to achieve batch-to-batch reproducibility? How do you guarantee the final quality of the product?
As manufacturers of pharmaceutical products in Spain and Europe, we must comply with Good Manufacturing Practices (GMP) as the main regulation. In terms of quality control, we comply with the European Pharmacopoeia and ICH guidelines for stability testing.
Product quality must be guaranteed, from the initial steps of product development (R&D) to the end of commercialization. And this must be ensured by all key roles in the product life cycle.
Our products are subjected, batch by batch, to strict quality controls to ensure their safety and efficacy. In addition, we guarantee quality by monitoring the product at each stage of its life cycle. For this purpose, there are periodic reviews (PQR) in which the critical parameters of the manufactured batches are reviewed and a statistical treatment is applied in order to detect trends and act accordingly.
- How does Asac Pharmaceutical Immunology adapt to the different international quality assurance regulations?
The main guidelines are available for public consultation. When we have to apply a new guideline, we perform a GAP analysis on that specific guideline to detect what things we have to adapt in our organization in order to comply with that standard.
- As a technical department, what are your plans for growth in the short and long term? How do you see Asac Pharmaceutical Immunology 10 years from now?
In the short term, we are working on different projects that will allow us to highlight our level of quality, enabling us to register our products in different countries.
Therefore, API will grow as a reference company in Immunotherapy treatments in the medium term.
We have many challenges to overcome, because regulations and market requirements are constantly changing both nationally and internationally. However, I believe that we have a great specialized team in our organization, which will be able to achieve any proposed objective.
