Validation

In order to guarantee mastery of implemented processes and to fulfil the regulatory requirements, two types of validation are regularly performed:

  • Process validation :
    • Generic media fill tests are carried out according to a frequency defined in GMP in order to prove the mastery of the aseptic filling process. In case of an atypical process, specific media fill tests can be performed
    • In order to ensure its efficacy, validation of the sterile filtration can be necessary
    • Customized validation methods for other parts of the process can be developed depending on the needs of the client
  • Validation of analytical and microbiological methods: According to GMP, analytical methods have to be validated in order to guarantee reliable and reproducible results. Analytical methods such as content and/or purity (by HPLC), endotoxins and microbiological methods (bioburden, sterility) are ┬ároutinely validated.