The Biocon’s quality management system is a special internal company infrastructure, including elements such as organizational structure, procedures, resources, and control. The quality system provides for the development of measures to ensure quality covering all production processes including the receipt, storage, and distribution of medicines.
The quality system and its functioning at CPC Biocon LLC means systematization and development of documentation, staff training, unconditional implementation of the provisions established by GMP, GDP, GSP, management and constant monitoring, updating and systematic improvements in the operation of the pharmaceutical warehouse. The quality system should be fully documented and its effectiveness shall be monitored.
Quality assurance of medicines during the “receipt” – “storage” – “supply” – “transportation” stages is the essential requirement for the quality system of Biocon.
The benefit of pharmaceutical products depends on the physical, chemical, and biological processes. These processes occurring during storage of medicines, can cause changes in their chemical composition or physical properties (formation of a precipitate, discoloration or aggregate state), and then a gradual loss of pharmacological activity or formation of impurities which change the pharmacological action. Temperature, humidity, light, pH, composition of air and other factors greatly influence all these processes. Therefore, the requirements to premises for the storage of medicines are very clearly defined.
During the construction and activity arrangement of Biocon Specialized Logistic Center, the national legislation requirements were taken into account:
- The Law of Ukraine, “On Pharmaceutical Products”
- License conditions of retail, wholesale and manufacture of pharmaceutical products.
and international norms:
- GDP – Good Distribution Practice of pharmaceutical products – an internationally recognized standard (set/Code of Rules) for wholesale trade in pharmaceutical products.
- GSP – Good Storage Practice of pharmaceutical products – an internationally recognized standard (set/Code of Rules) for storage of pharmaceutical products.
The requirements of European standards are also being met:
- Directive 2003/94EC in relation to Pharmaceutical Products for Human
- Directive 91/412/EC for Veterinary Pharmaceutical Products
- European guidelines on Good Distribution Practice of Pharmaceutical Products for Human (94/C 63/03)