The validation process consists of verifying in a certified and clearly documented manner that a process meets the requirements for which it it was designed. In the case of sterilisation, labeling a health product with a word "sterile" is only permissible when the validated sterilisation process has been used.
Validation should consist of the following: . Installation qualification(IQ) . Operational qualification(OQ) . Performance or process qualification(PQ) . Documentation . Microbiological performance qualification(MPQ) . Validation report and certificates
Comments