Esteve Química's quality management system includes cGMP and ISO9001 standards and is continuously controlled by our Quality Assurance Department. Mechanisms have been designed and implemented to guarantee compliance throughout the cycle of the product by means of the best procedures associated to our processes.
As a company committed to quality, Esteve Química is a member of the Active Pharmaceutical Ingredient Committee (APIC), a European group of manufacturers under CEFIC.
Esteve Química applies the entrepreneurial excellence model created by the European Foundation for Quality Management (EFQM) for continuous improvement of all its activities.
Our organization in the quality area is divided into three major areas: quality control, quality assurance and regulatory affairs.
All controls performed in our processes are described in detail in the three sections below:
| • | Quality Development Laboratory, which develops and validates analytical methods useful for the analysis of raw materials, intermediate products, process controls and finished products, and which is responsible for the introduction of new analytical technology. |
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| • | Process Control Laboratory, which analyzes and approves the raw materials, intermediate products and process controls required for the manufacture of our products. |
| • | Finished Product Laboratory which analyzes and approves all shipped out finished products. |
Securing a sound operation of the system involves a systematic evaluation of new operating procedures, due attention to internal and external audits, validation of processes and analytical methods, and review of equipment and facility qualifications. The edition and setup of Validation Master Plans involves the performance of all tasks according to the regulations in force.
This department performs all document-related tasks to respond to our clients and, where applicable, to National Health Authorities.
It also prepares and submits all official technical documentation (DMF, EDMF, CEP, PMF...) to applicable Health Authorities, and provides technical support to the clients in terms of analytical method advice, regulatory compliance at our production plants, stability studies and specific details on impurity profiles, among others.
