Pharmaceutical production is a delicate affair and for this reason requires validated processes and rigorous, detailed procedures such as to guarantee that the finished medicinal product always meets the requirements of authorised quality standards.
The maxim ‘an ounce of prevention is worth a pound of cure’ is especially relevant in pharmaceuticals manufacturing: here, the Quality Assurance department establishes rules, application of which can guarantee that the quality of the product manufactured exactly corresponds to the quality specifications authorised by the competent health authorities. The following are a few of the many tasks entrusted to Quality Assurance:
- to qualify our suppliers
- to draft the most suitable procedures for each production activity
- to scrutinise our procedures and assess every possible criticality by applying risk analysis techniques
- to standardise (validate) the production processes to guarantee repeatability
- to define the tests/inspections to be carried out during the various process phases found to be most critical
- before any product lot is placed on the market, to verify that all the manufacturing and Quality Control operations have been correctly completed, in order to guarantee the compliance of our products to the specifications approved
- after the product is on the market, to gather, evaluate and process any and all information which may contribute to further improving the ways in which we manufacture our medicinal products.
Quality, in production of a medicinal product, begins with the raw materials . Our suppliers are carefully selected and qualified before they become our suppliers: the first step is quality control of various samples of each raw material we need to procure; when a material meets our requirements, a team from the Quality Assurance department inspects the plant at which it is produced in order to verify the plant’s adherence to international quality standards. Only after a plant has been inspected and approved by Quality Assurance can we begin to purchase the raw materials it manufactures.
But quality raw materials are not enough to guarantee the quality of a medicinal product. We also need:
- to carefully fine-tune and monitor the manufacturing processes
- to perform quality checks on all components used, and quality control inspections of the manufactured medicinal products, prior to release to the market.
Florence - Manufacturing site
Quality Control Activities
Sterile Ampoules Production Department
Although the preventive actions we take are many and extensive, we don’t stop there. In order to best safeguard patients’ wellbeing, raw material and packaging material we use is tested and inspected by the Quality Control laboratories to verify its suitability for use.
Only after they have been approved by Quality Control can these materials be used for manufacturing our medicinal products – on which we run further tests to verify that the finished products are conformant with the authorised quality specifications.
Before any medicinal product can be sold, Quality Assurance runs a last check on the production documentation to be doubly sure that all the operations have been carried out correctly, that all the laboratory tests have given results conformant with expected values.