Quality
Active ingredients and modern technology as per EU GMP norms
Many of the components used in Alfa’s health products are natural and chemical active ingredients. Their positive effect in the human body depends on their quality and treating them carefully during the process of turning them into medicine or a food supplement. Alfa ensures them to meet according to GMP (Good Manufacturing Practice) guidelines.
These quality assurance standards were developed for pharmaceutical processes years ago by the WHO. Good manufacturing practice is thus a part of quality assurance and ensures that products are manufactured reproducibly in line with appropriate quality standards and are tested so that they are suitably safe for the health application purpose for which they are intended.
Certified quality of the source materials
The certified quality of the source materials used forms the starting point of the entire production process. What’s more, at Alfa every Alfa’s product, prescription medicines, over-the-counter medicines, medical devices and food supplements, is manufactured and inspected in-house according to strict legal requirements.
Alfa places the strictest possible quality requirements on the suppliers of active ingredients such as chemical or plant extracts. These certified suppliers are selected according to Alfa’s high-quality standards and inspected regularly. Most of the extracts used by Alfa come from inside and outside Europe and they are manufactured and processed to reach the high-quality standards required by Europe.
Following the rules of nature and EU norms
The active ingredient alone is not yet a medicine or a food supplement. Before an active ingredient or a mixture of ingredients can be placed on the market, the substances must be converted into a pharmaceutical form. At Alfa, we guarantee constant and verifiable quality for all products by ensuring our partners meet the specified manufacturing parameters and compiling comprehensive documentation of the validated manufacturing processes. Alfa, like every pharmaceutical company, is regularly inspected by the authorities to ensure that product quality complies with the German- and EU-guidelines.
Our formulation and manufacturing policies
As a quality conscious organisation, we are committed to meet or even exceed our customer’s expectations by maintaining high standards in all our activities, services, products and processes.
Our affiliate’s quality control group is involved throughout the entire development process, from drug substance and raw material control, through intermediate drug product testing, to finished drug product release testing and stability studies. This group implements the principles of “Quality by Design” (QBD) and “Design of Experiments” at all aspects.
Our affiliate’s research facility and manufacturing sites are fully compliant with cGMP, MHRA, and EU GMP requirements and house a number of new technological solutions. This allows us to assist our partners in the development of challenging and value-added products for the global market. Our permanent improvement program includes continuous investments in ultramodern equipment and extensive training of our personnel.