It is a common misunderstanding that validation exercises are not the concern of the on-site Qualified Person. This can often be experienced, particularly in larger companies, where the Validation department can be segregated, to some degree, from the Quality Assurance department.
It can easily happen, that once validation exercises are completed, the validation documentation can be forwarded to the QA department for the attention of the QA Manager. In many cases, this may not be the same person as the QP. Thus, a change to the validated status of the process can go ahead without the ‘specific’ attention of the QP.
QP Training Programme
The FDA have noted this in the past, and have come up with a method of eliminating this to some extent. This is done by explicitly requesting that the original manufacturing dossier is part of a QP’s training programme prior to that QP being mentioned on the licence.
This has only partly solved the problem and more specific steps are needed to ensure greater control. The following are some points , which, I believe are critical to ensure that the on-site QP is aware of validation changes.
- Full training for the QP on the manufacturing dossier.
- Full training for the QP on the change controls implemented since the original dossier submission.
- Pre-approval for the change control to be specifically granted by the QP.
- Final approval of the validation documentation to be specifically granted by QP.
- Notification in the batch record that a batch is part of the validation exercise.
- Minutes of meetings concerning validation to be forwarded to the QP.
- Presentation on the status of the validation exercise to be given at regular intervals to the QP by the Validation Department.
Summary
The QP can only make informed decisions relating to GMP, through proper formal channels of communication between the Validation Department and the QP. As a QP, it can be quite infuriating if the full extent of the validation exercise is not fully known from the outset. The approach must be clearly defined in the SOPs of the Validation Department and QA Department.
