Validation is an important element of quality assurance and is advised for storage of any medicines. The validation process maps and assures even temperature and air-distribution as per the design requirements.
Three types of tests that a validation consists of:
Installation Qualification (IQ) –
These tests validate whether the installation is meeting the requirements.
Operational Qualification Tests (OQ) –
These consist of a series of tests to ascertain that the cold room or freezer operates as specified.
Performance Qualification Tests (PQ) –
These consist of rigorous performance testing under practical conditions.
Ayjay Pharma advise you work with an independent 3rd party validation service to validate your new Ayjay Pharma system.