API Production
The Active Pharmaceutical Ingredient is the biologically active constituent of the medicine, responsible for the curative activity that one expects when taking a medicine.
It must be produced according to Good Manufacturing Practices (GMP) defined by regulatory authorities and binding on the legislative level.
How is an Active Pharmaceutical Ingredient produced?
APIs are produced according to Good Manufacturing Practices (GMP) defined by regulatory authorities. The entire system is controlled by very strict regulatory procedures.
License to manufacture certifying that the company works in accordance with the requirements of the EU legislation on GMP
A plant that has the adequately trained personnel, premises and equipment for the production and the conservation of each and every product
Quality systems and processes that guarantee the proper functioning of the equipment and the consistency and quality of the APIs produced
It is crucial for the API manufacturer to have a cutting-edge Research & Development (R&D) facility, enabling the transition from laboratory scale to pilot plant and then to full industrial scale. To achieve this an excellent level of technology is needed.
GMP standards require from manufacturers, inter alia, the validation of their equipment, processes, analytical methods and cleaning methods
Strict environmental, health and safety (EHS) standards are required to operate manufacturing plants
“Gold standards” are applied to meet excellence in industrial safety, environmental protection and health & safety at work