The production of active pharmaceutical ingredients is continuously supported by our Quality Assurance Unit.
Quality Assurance is a wide concept that covers all aspects in Alchemia that collectively or individually impact on the quality of the product.
Quality Assurance unit is responsible for organization and proper course of quality control processes concerning the release or rejection of finished products, intermediates, raw materials and packing materials.
Laboratori Alchemia can proudly claim that one of its strengths lies in Quality Assurance and Regulatory compliance, as evidenced by the excellent results of the inspections conducted by regulatory authorities.
This department verifies compliance to the GMP guidance of all specifications, master production instructions and all the procedures with possible impact on the quality of products along with validation protocols and reports.
Quality Control is another essential element of all Laboratori Alchemia activities and is always ready and willing to assist our customers in finding solutions to any kind of analytical problem.
Each step of synthetic routes is submitted to analytical monitoring, which involves testing of raw materials and intermediates, and in-process controls, thus providing high quality products with completely reproducible characteristics. The final products are thoroughly tested in order to verify that all the requirements (Pharmacopoeia or in-house specifications) are met.
The results are fully validated through analytical procedures which involve the handling of GC and HPLC techniques, UV, automatic titration instruments and all the analytical equipment needed for full certification of chemical quality.
Our Quality Control Department is always ready and willing to assist our customers in finding solutions to any kind of analytical problem. Laboratori Alchemia has implemented a data governance system to ensure that data are recorded, processed, stored and used in compliance with the principles of Data Integrity ensuring completeness, accuracy and reliability of data for their entire life cycle.
Our customers are always welcome to visit and inspect all of our plants because we believe that the close co-operation with our customers, as well as the sharing of experience and sometimes different points of view, enable us to challenge, maintain and improve our quality system.