Quality System Concept
Biocon quality management system is a special internal infrastructure of the company that comprises elements such as organizational structure, procedures, resources, control. The Quality System involves the development of quality assurance measures that cover all warehouse operations, including acceptance, storage, and distribution of medicines.
The establishment and functioning of the Quality System at CPC Biocon LLC means: systematization and development of documentation, personnel training, unconditional compliance with GMP, GDP, GSP, management and continuous monitoring, correction, and systematic improvements in the company’s activities. The Quality System is fully documented and its effectiveness is monitored.
Ensuring the quality of medicines at the “acceptance” – “storage” – “release” – “transportation” stages is a basic requirement for the Biocon Quality System.
Any processes that occur during storage of medicines may lead to changes that may affect the physical properties and pharmacological activity of a medicine. Temperature, humidity, light, and other factors have a great influence. Therefore, requirements to premises for storage of medicines are strictly regulated.
Requirements of the national legislation on the circulation of medicines drugs were taken into account, during construction and organization of Biocon Special-Purpose Logistics Centre.
as well as international practices:
GDP (Good Distribution Practice) is an internationally recognized set of rules for wholesale distribution of medicines.
GSP (Good Storage Practice) is an internationally recognized set of rules for storage of medicines.
The requirements of the following European standards are equally met:
- Guidelines 2003/94EC on medicinal products for human use
- Guidelines 91/412EC on veterinary medicinal products