ABSTRACT
So far we have considered all of the stages of an isolator project up to checking the work carried out on-site (IQ and OQ), including checking the sterilisation process, where applicable. The next stage is to train the operators and validate the working of the isolator, perhaps first with inert materials and then with the final product process. This is the PQ stage of the project, very much bound up with the term validation. The term validation is an all-embracing term and includes IQ and OQ discussed in Chapter 6 and, indeed, really begins with the URS mentioned at the beginning of Chapter 5. Where sterile processing is concerned, validation is mostly taken up with proving that the sterilisation of the isolator is satisfactory. A more general definition of PQ has been given as follows:
Performance Qualification is a two-stage process:
1. Confirmation, with evidence, that the system performs as described in the DQ
2. Confirmation, with evidence, that it continues so to do
In Chapter 5, Figure 5.1 shows the interrelationship of all the stages in the validation process and emphasises the need to address validation early on in any project.
