Cold chain and temperature management

The important part of our business is associated with temperature sensitive pharmaceuticals. According to GDP requirements we ensure sustainable cold chain by means of:
Dmitrii Chernyi

Quality system manager

dchorniy@bcph.com.ua

  • Complete tracking of temperature storage conditions
  • Validation of storage areas
  • Qualified shipment
  • Documentation
  • Procedures to handle temperature excursions
To ensure appropriate transportation conditions BCPh implemented system of cold chain management in transit. We use qualified shippers, refrigerators and validated data loggers.

Our standard process flow:

  • Develop requirements documents
  • Component specification
  • Design testing
  • Develop OQ protocol
  • Develop PQ protocol
  • OQ testing
  • PQ testing